Biostatistics Director remote jobs

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle. This position leads a cross-functional, integrated quantitative team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs statistics, real-world evidence (RWE), safety/pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and advanced analytics. The role ensures consistency and scientific excellence across studies, indications, and evidence types-while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for solid tumor assets. Responsibilities and Accountabilities: Strategic Statistical Leadership * Serve as the compound-level statistical lead for solid tumor oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions. * Lead development of integrated statistical strategies across all relevant study types and functions (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). * Align statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs. Cross-Functional Quantitative Team Leadership * Lead and coordinate statistical and analytics contributions from a broad QSEG team, including: * Clinical trial biostatisticians * Exploratory oncology statisticians (e.g., tumor burden modeling, subgroup/signal detection) * Medical Affairs statisticians * Statistical programmers * Biomarker/statistical genetics experts in oncology * RWE analysts/statistical epidemiologists * Safety/PV statisticians * Advanced analytics and modeling specialists * Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. Regulatory and HTA Engagement * Represent Astellas on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). * Guide preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers. * Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Innovation and Methodological Excellence * Champion the use of oncology-appropriate innovations, including Bayesian designs, adaptive trial designs, external controls, tumor-agnostic approaches, and AI/ML tools to enhance study design and signal detection. * Promote exploratory data analysis, modeling, and simulation to support rapid development decisions in Solid Tumor trials. * Integrate clinical, biomarker, safety, and real-world evidence to drive cohesive, data-driven development and access strategies. Mentorship and Capability Development * Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career growth. * Share knowledge and best practices across study teams and therapeutic areas. * Contribute to internal training, methodology development, and talent pipeline initiatives. Governance and Cross-Functional Influence * Participate in global asset governance and development team meetings, influencing decisions with rigorous statistical insight. * Collaborate with Clinical Development, Medical Affairs, Regulatory, Market Access, and Commercial to ensure alignment on evidence planning. * Lead or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks.

We are hiring for an Associate Director / Director, Biostatistics This role is located in Washington, DC and is fully onsite. Our client is seeking a highly experienced Associate Director / Director of Biostatistics to lead statistical strategy and execution across their clinical development programs. This is a key leadership role with broad influence on study design, data integrity, regulatory submissions, and the growth of the Biostatistics function. In this role you will: • Serve as the lead statistician for multiple clinical studies across diverse therapeutic areas • Drive clinical trial design, protocol development, and creation of robust Statistical Analysis Plans (SAPs) • Lead data analysis, TFL generation, interim analyses, and integrated summaries of efficacy and safety • Provide strategic statistical consultation and collaborate closely with clinical, medical, regulatory, and data teams • Manage internal statisticians, contract resources, programming teams, and CRO biostatistics support • Represent Biostatistics in cross-functional project and study team meetings • Support regulatory interactions, responses, and submission-related activities • Identify potential statistical risks, propose solutions, and bring in external experts as needed Requirements: • PhD in Biostatistics or Statistics • 5+ years of clinical trial experience (pharmaceutical or CRO) • Deep knowledge of clinical trial methodology, ICH/GCP, and regulatory expectations • Strong, hands-on experience with SAS and R / S • Exceptional communication, leadership, and organizational skills • Ability to collaborate effectively in a dynamic, fast-paced environment Here you'll have the opportunity to influence clinical development at a strategic level, mentor talented statisticians, and contribute to meaningful innovations that impact patient lives. Salary - $175k-240k base + bonus Fantastic benefits package including equity and unlimited PTO If you are interested or know someone who might be, please reach out to me at **************************!

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Director of Biostatistics will provide strategic statistical leadership for pharmacokinetic (PK) and pharmacodynamic (PD) studies across all phases of clinical development. This role partners closely with Clinical Pharmacology, Clinical Biomarker, Regulatory Affairs, and Clinical Development to ensure robust study design, insightful data analysis, and timely support for global regulatory submissions. Deep expertise in PK modeling, including non-compartmental and population PK analysis, and experience with regulatory interactions are essential. Experience in relevant disease areas-particularly oncology, immunology, or inflammation-is preferred. The position requires effective cross-functional collaboration with clinical teams, SAS programming, data management, clinical operations, medical writing, and other key stakeholders. Essential Functions of the job: ·Provide strategic biostatistical leadership across all PK/PD-related studies and development programs. · Collaborate with Clinical Pharmacology to design studies involving PK, ADME, bioavailability, and drug-drug interactions. · Develop and oversee statistical analysis plans (SAPs) for PK/PD endpoints, ensuring methodological rigor and execution quality. · Conduct or supervise exploratory exposure-response analyses, including covariate modeling, visualization, and interpretation to inform clinical and regulatory strategy. · Ensure high-quality, compliant, and timely delivery of statistical components for regulatory submissions (e.g., INDs, NDAs, BLAs, and global equivalents). · Communicate statistical concepts, methods, and results clearly to both technical and non-technical audiences, including clinical, regulatory, and senior leadership teams. · Partner with internal teams and external stakeholders-including CROs, consultants, and partner companies-to align on study design, analysis, and reporting. • Establish, maintain, and continuously improve standard operating procedures (SOPs), work instructions, and processes for PK/PD data analyses to ensure consistency, compliance, and best practices across all studies and projects.Top of Form · Mentor, guide, and develop junior statisticians and contractors involved in PK/PD activities, fostering technical excellence and professional growth. Supervisory Responsibilities: NA Travel: NA Qualifications: Master's Degree with at least 7+ years' experience, or Ph.D. with at least 5 years' experience Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $180,200.00 - $240,200.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

Putnam is seeking to hire Director of Real-World Evidence [RWE] & Biostatistics. This role offers the opportunity to join a global team of more than 30 statisticians, mathematicians, epidemiologists and health economists. Our team conduct statistical and quantitative analyses in the context of HEOR studies and Health Technology Assessment (HTA) submissions. This includes analyses of electronic medical records and health insurance data, registries, chart reviews, and other types of real-world data, indirect treatment comparisons, meta-analyses, and analyses of clinical trial data. As a senior leader in our RWE & Biostatistics team, you will play a key role in overseeing the acquisition and delivery of work, in ensuring our work meets the commercial and scientific needs of our clients and in contributing to the strategic direction of the team. This role will be US based out of one of our East Coast hubs - Boston or New York City (remote work may be an option). Please note preferences on application form. Responsibilities include, but are not limited to: Lead or contribute to business development activities including proposal development and client relationship building Oversee or lead the design, programming and execution of complex RWE & statistical analyses Oversee or lead the preparation of study documents, including protocol, statistical analysis plan and report Oversee or lead the delivery of quantitative HEOR/HTA projects, with a particular focus on projects involving statistical analyses to synthesize data from multiple sources (pairwise meta-analyses, mixed treatment comparisons/network meta-analyses, etc.) and integration of RWE. Oversee or lead the provision of statistical input into the Evidence department projects portfolio, in line with HTA guidelines Oversee or lead the development of publications (abstracts, posters, manuscripts) Lead the preparation and delivery of presentations to clients Oversee or lead the management of assigned projects, including the management of project teams, clients, schedules and budgets Line management/mentoring Lead internal training programs and operational improvements Oversee or lead methodological work on novel statistical approaches for HEOR/HTA Desired Skills and Experience Preferably Masters or PhD in mathematics, statistics, mathematics, health economics, or related discipline. Six (6) years minimum related work experience Extensive experience of working with US real world databases, including claims and EHR databases Extensive statistical programming experience Knowledge of standard approaches for quantitative evidence synthesis and familiarity with emerging novel/advanced approaches is a bonus Proficiency in using Microsoft Word, Excel and Power Point Team-oriented mind-set Excellent interpersonal and communication skills, in English, especially the ability to explain complex concepts to non-specialists Ability to meet short deadlines with high quality results Ability to effectively manage and juggle between multiple tasks and projects Effective team management experience Ability to work in a team and independently. What we offer you! Competitive compensation packages Exceptional professional growth and promotion opportunities Working in a team-based environment on a global scale Leadership & Development programs at each key milestone Hybrid working model. Global presence - offices and openings in many countries. Great benefits [paid time off, 401k, health insurance options, and more] Company Description Putnam, an Inizio Advisory company, is a leading scientific and strategic consulting partner that helps the global life science community make confident, impactful decisions and develop bespoke solutions that support bringing life-changing innovations to clinicians and patients. For more than 30 years, we've taken a client-centric approach uniquely combining our strategic mindset and global cross-functional capabilities to deliver unrivaled depth across therapeutic areas, healthcare sectors, and technology platforms to maximize the human impact and commercial success of client innovations. We believe that to create real, lasting change on human health, we must bring out the best in our people, in every way and at every level. We offer a boutique-firm feel inside a global enterprise, opening the door to limitless opportunities to kickstart your career or hone your expertise. Built on the pillars of empowerment, collaboration, and meaning, we're proud to offer a fulfilling environment where world-class advisors can come together to shape the future of healthcare for the better. Serving the life sciences industry, including the top 20 global biopharmaceutical companies, consistently ranked as one of the top consulting firms by Vault, and maintaining a true global team of experts with 400+ talented team members sitting across 3 continents, we offer a unique opportunity to play a central role in supporting our clients. Diversity, equity, and inclusion are tenets of our core values. We strive to create a culture and environment that fosters belonging and authenticity across all levels and values individuals for their skills, experience, diverse backgrounds, and unique perspectives. Collectively, DEI serves as a foundational element of who we are and how we work with our clients and with each other. Our core values: Team Excellence Strategic Passion Diversity We are proudly part of Inizio Advisory, a trusted advisor for pharmaceutical and life science companies that turns science into strategy, supporting execution at every stage of the product and patient journey from early commercialization to launch and beyond. Offering market research and insights; strategy, people and transformation consulting; and commercial benchmarking delivered through sector specific connected solutions and intelligence, Inizio Advisory helps create long-term value for clients and their patients. Don't meet every job requirement? That's okay! Our company is dedicated to building a diverse, inclusive, and authentic workplace. If you're excited about this role, but your experience doesn't perfectly fit every qualification, we encourage you to apply anyway. You may be just the right person for this role or others.

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do The Associate Director, Biostatistics is responsible for statistical activities in support of Medical Affairs activities, including contributing to providing scientific and methodological expertise to support medical strategy, publications, and external engagements. This role will focus on the design, execution, interpretation, and communication of analyses that inform medical decision-making, health outcomes, and scientific exchange. A successful candidate will also interact with internal and external cross-functional study teams, supporting interactions with the medical community, and manage contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Responsibilities Provide statistical input to medical publications, scientific congresses, and external collaborations Apply appropriate statistical methodologies supporting medical insights, value demonstration, safety monitoring, and lifecycle management Ensure high-quality statistical deliverables that meet scientific and regulatory standards Partner with colleagues in Medical Affairs, HEOR, Clinical Development, and other cross-functional teams to align statistical activities Translate statistical concepts into clear insights for medical and scientific stakeholders Stay current with evolving statistical methods, data sources, and regulatory expectations related to real-world evidence CRO / Vendor Oversight: Establishes procedures through regular interaction, setting expectations on deliverables and timelines to guide the CRO biostatistician and statistical programmers. Ensures deliverables are accurate and delivered according to the timelines Where You'll Work This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office. Who You Are PhD or Master's degree in Biostatistics, Statistics, or related field 7+ years (PhD) or 10+ years (Master's) of biostatistics experience in the pharmaceutical/biotech industry Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments Strong analytical and problem-solving skills; able to identify and investigate issues and causes independently and formulate potential solutions Excellent written and verbal communication skills, with the ability to engage both technical and non-technical audiences Excellent programming skills in SAS and/or R Ability to work as a part of a cross-functional team in a fast-paced environment and to work collaboratively with external partners and vendors Experience contributing to medical publications and scientific communications preferred Familiarity with HEOR and real-world evidence analysis preferred Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$195,000-$230,000 USD

At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Role: The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans. Responsibilities: Compound/Indication Level Act as lead and main point of contact related to Statistics for designated compound/indication Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficiencies Engage with regulatory authorities on compound/indication level discussions Acts as a role model Ensures consistency of statistical methods and data handling across trials Ensures all compound/indication related work and information is shared between biostatisticians involved in the compound and with the vendor Supports compound responsible programmer in developing an integrated database specification CDT member: Responsible for giving statistical input to overall strategy and the synopsis development in the CDT Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable Drive design and synopsis development together with relevant stakeholders Ensure transparent communication to relevant stakeholders from the CDT Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles Trial Level Represent Genmab during meetings/congresses and courses and perform professional networking Engage with regulatory authorities on trial level discussions Arranges/attends lessons learned to share learnings Represents Genmab during Key Opinion Leaders meetings Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable Ensures state of the art statistical work which includes but is not limited to: Applying adequate methods for which a solid scientific foundation exists Ensure proper documentation of work done Keep oversight and QC essential documents/data provided by vendors Ensure trial related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCP CTT member: Participate and represent Biostatistics Review and provide input to protocol and amendment development Perform vendor oversight according to applicable SOPs Give input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and listings etc. Review assay validation reports, as applicable Perform exploratory analysis, ad hoc analyses, and modelling of data Review and approve randomization and stratification plans Perform UAT of Randomization part of the IRT system as applicable Ensure procedures for blinding are in place as applicable Support timely delivery of statistical deliverables Responsible for planning and conducting trial result meetings Review and approve the CSR Attend trial and investigator meetings if/as needed Collaboration with Genmab Global Drug Safety: Participate in definition, review, and approval of data packages for Data Monitoring Committees Review and approve any amendments, corrections, and updates of data packages Support regulatory submission/filing activities Experience: Master's or PhD in a statistical discipline 8+ years of experience in relevant area preferred, or demonstrated capability Experience in statistical analysis, modelling and simulation and adaptive trial designs Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics Experience with the relevant regulatory requirements for biostatistics processes and SOPs Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions Experience directing multiple complex projects/studies in a technical capacity Proven performance in earlier role/comparable role For US based candidates, the proposed salary band for this position is as follows: $145,440.00---$218,160.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives. When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary Plans: Critical illness, accident, and hospital indemnity insurance Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so! Locations Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate. About Genmab Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO ) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com). Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. The Role: Reporting to the Executive Director, Biostatistics, this position is responsible for collaborating with both internal and external stakeholders to deliver the execution of our Biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup. Key Responsibilities: Provide statistical inputs into protocol and clinical study report development, statistical analysis plans, interpretation of statistical analysis results, randomization plans. Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, specifications of variable derivations, and all deliverables from outside vendors or internal programmers. Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory). Ensure that all study level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards. Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports. Oversight statistics and programming vendors. Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making. Requirements: PhD or MS in Statistic, Biostatistics, Mathematics, or related field 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area Knowledge of relevant FDA, EU, ICH guidelines and regulations Understanding of drug development Demonstrated ability to collaborate with diverse sets of stakeholders Strong written and oral communication skills with attention to detail Desire to work in a fast-paced, innovative environment Natural collaborator who enjoys working on a cross-functional team Work Environment: Remote-based; access to Immunovant's NYC and North Carolina offices available Dynamic, interactive, fast-paced, and entrepreneurial environment Domestic or international travel may be required ( Salary range for posting$190,000-$210,000 USD Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

The Director, Biostatistics will independently perform highly scientific statistical functions in support of the company's Global Medicines Development and Affairs (GMDA) area on new and complex issues. The incumbent will complete work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results if needed. In addition, the Director provides independent strategic and technical contributions. The incumbent possess an excellent knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. As a people manager within the organization, has financial accountabilities and human resource responsibilities for assigned staff. Key Duties and Responsibilities: Directs one or more projects including multiple clinical trials, observational studies, or real world data (RWD) investigations. Also includes presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards. Manage a team of direct reports including their performance and development. Mentors project team members and promotes effective team operation and cross-functional collaboration. Possesses an expert understanding of modern drug discovery and development processes. Represents Biostatistics as a member of cross functional teams, providing strategic input and expert technical guidance to elicit meaningful and/or productive outcomes. Sets the technical and scientific directions of the project(s). Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results. Leads collaboration with statistical programming and other functions to ensure high quality and technically sound delivery of TFLs. Leads or contributes to external interactions with regulators, payers, review boards, etc. Authors or co-authors methodological or study-related publications and posters. Leads implementation of innovative designs and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others. Contributes to departmental working group efforts on key various technical and operational issues. Independently undertakes new and highly complex issues requiring advanced analytical thought. Completes work in a resourceful, self-sufficient manner; conceptualizes alternative, and at times untested, approaches to achieve desired results. Maintains and expands in-depth knowledge of related disciplines with a drug developer mindset. Knowledge and Skills: Prior staff management experience Project management and project team oversight Expertise with SAS and R statistical software Demonstrated expertise in advanced/complex statistical methods used in drug development Deep skill in critical thinking and logical problem-solving Excellent written and verbal communication skills with the ability to influence opinions of peers and managers Excels in a team environment Collaborates well with non-statisticians and can effectively explain complex concepts to non-technical audiences NDA/MAA experience and direct dealings with USA/European regulators. Education and Experience: Ph. D. in Statistics or Biostatistics. Typically requires 10 years of experience with a Ph.D. #LI-AR1 #LI-Hybrid Pay Range: $164,800 - $247,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

This is an exciting opportunity to lead a team of statisticians advancing adoption of Natera's oncology portfolio of cutting-edge molecular diagnostic tests. As an Associate Director in Biostatistics, you will leverage your deep applied statistics and leadership background to guide the design and interpretation of Natera sponsored clinical studies ensuring scientific rigor and meaningful clinical insights across oncology programs. This position will play a central role in defining the team's vision, fostering excellence in biostatistics deliverables, and cultivating a high-performing, collaborative environment that drives long-term success. PRIMARY RESPONSIBILITIES: Direct a team of biostatisticians, taking responsibility for their individual deliverables and growth (technical and professional) Oversee Biostatistics contributions to oncology product clinical validation projects Lead development of novel statistical approaches and simulations to support innovative study designs. Produce, review, and standardize high-quality documentation for cross-functional internal and external collaborators and stakeholders Identify risks, communicate concerns, and champion solutions to cross-functional project teams Continuously improve the efficiency and efficacy of team through innovative techniques and strategies Manage contracts and deliverables provided by CROs as needed. QUALIFICATIONS: Advanced degree (Ph.D. or M.S.) in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred) 7+ years of experience in clinical trial biostatistics Strong knowledge of survival analysis, censoring, and other advanced statistical techniques relevant to oncology Expertise with study design innovation and power/simulation approaches Proven track record in mentoring and developing junior staff Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences and foster collaborative, cross-functional partnerships KNOWLEDGE, SKILLS, AND ABILITIES: Strong technical leadership and strategic thinking. Proven success leading and developing teams. Deep expertise in statistical methods for diagnostics and clinical trials, including FDA requirements. Effective collaborator across diverse technical disciplines. Clear, high-quality scientific and technical communication. Familiarity with NGS, ct DNA, and molecular oncology preferred. The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$174,400-$218,000 USD Compensation & Total Rewards This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations. This position is also eligible for additional compensation and benefits through Natera's robust Total Rewards program, including: Annual performance incentive bonus Long-term equity awards Comprehensive health benefits (medical, dental, vision) 401(k) with company match Generous paid time off and company holidays Additional wellness and work-life benefits Compensation Range $174,400-$218,000 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cf DNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit *************** Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: ********************************************************************** Please be advised that Natera will reach out to candidates with ************* email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

The Senior Biostatistician is expected to have a thorough understanding of advanced statistical methods and develop an understanding of innovative statistical approaches (e.g., simulations, adaptive designs, Bayesian statistics). The Senior Biostatistician is also expected to have a thorough understanding of the DMC process and may assume the functional lead role within a designated DMC project team, involving facilitation of DMC meetings, awareness and active monitoring of project budgets, hours budgeted/spent, timelines, and will be actively contributing to systematic regular project status reviews. We offer structured peer mentoring and technical and management career development opportunities with exposure to clinical trials in many disease indications with a range of statistical methods across drugs, biologics, devices, and vaccines. Master's degree or PhD in Biostatistics, Statistics, or related field. With PhD, a minimum of 3 years of industry experience, with MS a minimum of 5 years of industry experience. SAS programming skills; R a plus. Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills. Prior DMC experience required. Develop and review input for DMC activities (charter, statistical analysis plan, mock shells, specifications, analysis, programming and validation, DMC meetings, meeting minutes). Review and perform oversight of analysis plans, statistical analyses, outputs, and datasets provided by another vendor. May serve as functional lead on DMC project teams. Liaise with client/DMC for clarification on any technical decisions and propose most efficient, successful solutions. Interact and coordinate with client staff and DMC members. Participate in project team meetings and DMC meetings on a regular basis. Provide statistical advice in project team setting. Identify risks to project deliverables and timelines, develop and implement the mitigations for these risks. Stays current regarding requirements to ensure quality control and audit readiness of all assigned biostatistics deliverables as well as accuracy and reliability of statistical analysis results. Accurately review and report project forecasting and actual hours as scheduled per agreed scope for biostatistics tasks. Understand and follow all relevant SOPs. Understand and adhere to project specific clinical protocols. Mentor Biostatisticians. May coordinate activities of other personnel.

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest. To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Biostatisticians for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Key Accountabilities: 1. Leadership and Project Management: Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations. Lead assigned projects by applying project management skills, statistical and programming techniques; achieve quality and on time delivery of deliverables, earn client's trust and repeat business. 2. Statistical Planning and Methodologies: Provide statistical expertise for design, analysis and reporting of clinical trials and research projects. Contribute to the writing of statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes. Write Statistical Analysis Plans (SAPs) and properly address Peer Statistician review comments. Create and maintain Statistical and Programming Quality Control (QC) and QA Plans for assigned projects. Provide input to unblinded data management plan when required. Assist in research and development of statistical methodologies and processes. 3. Statistical Programming: Develop and/or review ADaM dataset specifications. Review and provide input to SDTM dataset specifications when required. Perform QC validation of analysis datasets and TLGs. Perform third level review of dry runs and final run. Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues. Review and provide input to the Analysis Data Reviewer's Guide, discuss and incorporate Data Standards Reviewer's review comments to ensure quality of the document. 4. Statistical Analysis and Reporting, and Publication Support: Perform statistical analysis as per SAP, and address peer/QC review comments and findings. Perform statistical validation of core results, address additional QC validation comments and findings on the core results. Plan and conduct or contribute to the trial results reporting/dissemination meetings. Under supervision contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results. Write statistical report or statistical sections of the CSR. Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters. 5. Supporting Clinical Data Collection and Cleaning: Provide statistical input to Case Report Forms (CRF) design and database/variable structure. Provide statistical input to non-CRF data collection and acquisition methods and approaches. Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification. Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution. Perform ongoing assessment and communication of data quality issues, including protocol deviations. Assist data management and trial management team in preparing for database lock. 6. Complete job required and project-specific training. Comply with applicable Everest and trial sponsor's policies, SOPs, and work instructions. 7. Properly archive study files in accordance with trial sponsor's requirements. 8. Plan and carry out professional development activities. Qualifications and Experience: A Ph.D. degree in statistical science, mathematical analysis or related fields plus 2 years highly relevant experience or a Master's degree plus 4 years highly relevant experience, with demonstrated ability and sustained performance. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at ***************** Estimated Salary Range: $130,000 - $160,000. We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #LI-Remote #LI-TK1 #INDHP

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. Why you'll love working at Axogen: Friendly, open, and fun team culture that values unique perspectives Company-wide dedication to profoundly impacting patients' lives Comprehensive, high-quality benefits package effective on date of hire Educational assistance available for all employees Matching 401(k) retirement plan Paid holidays, including floating holidays, to be used at your discretion Employee Stock Purchase Plan Referral incentive program Axogen Mission and Business Purpose Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care. Job Summary of the Biostatistician The Biostatistician is responsible for the design and conduct of clinical research studies including developing statistical analysis plans, performing basic and complex statistical analysis, interpretation and reporting of study results and other required activities as needed. Responsibilities include providing data analysis input to meet project objectives, contributing to statistical analysis sections of IRB and grant applications, developing and executing statistical programs to perform analyses and prepare data displays, drafting analysis and results sections for clinical study reports and scientific papers, and supporting general publication of study findings. Requirements of the Biostatistician A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 5 years' relevant experience or a master's degree plus 8 years' relevant experience with demonstrated ability and sustained performance at the Ph.D. level. Minimum 5 years of experience working in the biologic/biotechnology, pharmaceutical, and/or medical device industry Demonstrated success in delivering on goals and being part of fast-moving, collaborative team Broad regulatory understanding of functions and processes involved in pharmaceutical, biologic, and/or medical device product development Must demonstrate strong interpersonal, written, and oral communication skills across various levels of management and demonstrate the ability to manage differences and needs between multiple stakeholders Responsibilities of the Biostatistician The specific duties of the Biostatistician include but are not limited to: Leadership and Project Management: Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations. Apply project management skills, statistical and programming techniques, and achieve quality and on time delivery of deliverables. Coordinate activities with project/program overall management personnel to achieve program objectives. Under supervision may represent the company to interact with regulatory agencies regarding matters relating to the statistical areas of the responsible projects/programs. Statistical Planning and Methodologies: Provide strong statistical expertise for design, analysis and reporting of clinical trials and research projects. Write statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes. Write Statistical Analysis Plans (SAPs) and properly address quality control (QC) review comments. Create and maintain Statistical and Programming QC and QA Plans for assigned projects or programs. Provide input to unblinded data management plan when required. Participate or lead research and development of statistical methodologies and processes. Lead efforts in planning, researching and designing statistical methods and approaches in solving complex trial data analysis and operational issues. Statistical Programming: Develop and/or review ADaM and/or SDTM dataset specifications. Lead efforts in resolving complex data derivation and data handling issues. Perform statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or perform QC validation of these datasets and TLGs. Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues. Review and provide input to Data Standards Review comments to ensure quality of documents. Perform QC programmatic checks on core study results as well as overall quality/consistency review of statistical TLGs. Statistical Analysis and Reporting, Publication Support: Perform complex statistical modeling and analyses, implement new statistical analysis methods and strategies. Perform statistical analysis as per SAP, and address peer/QC review comments and findings. Perform statistical validation of core results, address additional QC validation comments and findings on the core results. Plan and conduct or contribute to the trial results reporting. Contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results. Write statistical report or statistical sections of the CSR, or perform peer review of the contents. Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters. Supporting Clinical Data Collection and Cleaning: Provide statistical input to Case Report Forms (CRF) design and database/variable structure. Provide statistical input to non-CRF data collection and acquisition methods and approaches. Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification. Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution. Perform ongoing assessment and communication of data quality issues, including protocol deviations. Assist data management and trial management team in preparing for database lock. Perform other duties as directed by the Supervisor Location Remote OR 111 West Oak Ave., Tampa, FL 33602 #LI-AC1 #LI-REMOTE Benefits/Compensation This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions. Salary Range$122,386-$152,982 USD Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

As an experienced Principal Biostatistician in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials for renowned, innovative and global top pharmaceutical and biotech companies. In this role you will develop and review Statistical Analysis Plans for data presentation, analyses, and provide programming support to your multidisciplinary global project team. About the team You will be part of a long-lasting partnership with one of our top sponsors (a 10-years relationship) for which we pride ourselves on being the preferred provider. In this team, you will work with over 150 people globally, all with great experience and ready to support you at any given time since we work globally from the US to APAC. What else can you expect from us? Rewarding and meaningful work in an established, diverse, highly profitable and respected global company Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc. A genuine work life balance Flexibility in working hours A thorough onboarding with support from your personal mentor Excellent training and career development opportunities, as well as support with advancing your individual education Strong support from your Fortrea Line Manager and your team, as well as from more than 19,000 colleagues worldwide Your responsibilities: Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings Perform project management activities for identified projects including resource planning, timelines and milestone management Serve as Data Monitoring Committee Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery Review Case Report Form and other study specific specifications and plans Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant Preparation and review of randomization specifications and generation of randomization schedules Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences Attend bid defense meetings for complex studies Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives Represent the department during audits. Your profile: Degree in a relevant field such as statistics, biostatistics, public health, etc. Masters degree strongly preferred. Solid experience (10+ years) of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company Ability to program in one or more statistical software packages (SAS ) used to conduct statistical analyses; SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis Proven professional experience with SDTMs, ADaM datasets and TFLs Proven ability to effectively communicate statistical concepts A good knowledge of the overall clinical trial process Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail Business fluency in English - both verbal and written - is a must Physical Demands/Work Environment: Work Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Pay Range: $130,000-$150,000 USD base annual salary (US Candidates only) Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. The application deadline is December 15, 2025. #LI-REMOTE #LI-LL1 Learn more about our EEO & Accommodations request here.

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary The Senior Biostatistician carries out tasks assigned within the timelines and the standards of quality, while providing supervision to biostatisticians, preparing Statistical Analysis Plans and writing the statistical methodology and results sections of reports. The Senior Biostatistician provides statistical input to the design and review of Protocols and Case Report Forms and prepares and performs trainings of other staff and clients on statistical methodology and statistical principles. Job Description THE SENIOR BIOSTATISTICIAN ROLE The Senior Biostatistician carries out tasks assigned within the timelines and the standards of quality, while providing supervision to biostatisticians, preparing Statistical Analysis Plans and writing the statistical methodology and results sections of reports. The Senior Biostatistician provides statistical input to the design and review of Protocols and Case Report Forms and prepares and performs trainings of other staff and clients on statistical methodology and statistical principles. ESSENTIAL JOB FUNCTIONS* Writes and reviews the statistical methodology and results sections of reports Review of Statistical analysis (tables, figures and listings) and specifications of clinical trials Performs sample size calculation Writes Blind Review plans and reports Writes and review statistical parts of scientific articles Prepares and reviews Statistical Analysis Plans Advises other staff and clients on statistical methodology and statistical principles. Participates and conducts Blind Review meeting. Supports the presentations to clients and manages the technical communications with client when assigned as lead statistician to a study Create SAS and/or R programs for Datasets and TLFs validation Prepares and performs training to internal/external staff on statistical methodology and statistical principles Provides statistical input to the design and review of Protocols and Case Report Forms Participates to DMC/DSMB meetings Provides support to DMC/DSMB charter preparation Reviews the specifications for analysis datasets Conducts other activities as required PREPARATION, KNOWLEDGE, SKILLS & ABILITIES Master's degree in Statistics At least 3 years of experience in Biostatistics SAS Programming, Good R Programming, Basic/Good Broad Range of Statistical methodology skills, Very Good ICH E9 Statistical Principles for Clinical Trials, Very Good English, Good MS Office Suite, Good Professional Trustworthy Ability to effectively prioritize Quality focused Personable Attitude Willingness to learn Team Player Effective Stress Management Techniques Learning Agility Ability to Manage Conflict Problem Solving Skills Effective Verbal Communication Skills Commercial and Technical Writing Skills Networking Skills Languages English Education Bachelor of Arts (BA): Statistics Contract Type Regular

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is hiring a Principal Biostatistician to work remotely. The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert. Location: United States - Remote Key Accountabilities: Operational Execution Provide broad statistical support, including trial design, protocol and CRF development on specific studies Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review Business Development Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings General Activities Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis Understand, apply and provide training in extremely advanced and sometimes novel statistical methods Contribute to the development and delivery of internal and external statistical training seminars and courses Review position papers based on current good statistical practice Interact with clients and regulatory authorities Review publications and clinical study reports Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results) Additional responsibilities as defined by supervisor/manager. Skills: Good analytical skills Good project management skills Professional attitude Attention to detail Thorough understanding of statistical issues in clinical trials Ability to clearly describe advanced statistical techniques and interpret results Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines) Prior experience with SAS programming required Ability to work independently Good mentoring/leadership skills Good business awareness/ business development Knowledge and Experience: PhD or MS in Statistics or related discipline with substantial experience The knowledge of pharmacokinetic data is an advantage Competent in written and oral English in addition to local language Education: PhD in Statistics or related discipline, MS in Statistics or related discipline EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Beacon Biosignals is on a mission to revolutionize precision medicine for the brain. We are the leading at-home EEG platform supporting clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our FDA 510(k)-cleared Waveband EEG headband and AI algorithms enable quantitative biomarker discovery and implementation. Beacon's Clinico-EEG database contains EEG data from nearly 100,000 patients, and our cloud-native analytics platform powers large-scale RWD/RWE retrospective and predictive studies. Beacon Biosignals is changing the way that patients are treated for any disorder that affects brain physiology. Beacon Biosignals is seeking an experienced data scientist/biostatistician to help us collect, ingest, analyze, and interpret petabytes of EEG data to drive advancements in brain health. This role is part of the Biostatistics function within Beacon's Data Science Group. The Data Science Group is a diverse set of talented, dedicated individuals with expertise across neuroscience, biostatistics, data wrangling, and more, who collaborate across the organization and externally to answer scientific questions with data. In this role, you'll work in cross-functional teams to support Beacon's Life Sciences engagements with industry partners that power novel therapies for patients with neurological, psychiatric, and sleep disorders. You'll also collaborate with scientists, engineers, and clinicians to draw meaningful insights from real-world data and accelerate neurobiomarker discovery. This role reports to the manager of the Data Science Group. At Beacon, we've found that cultural and scientific impact is driven most by those who lead by example. As such, we're always seeking out new contributors whose work demonstrates innate curiosity, a bias toward simplicity, an eye for composability, a self-service mindset, and-most of all-a deep empathy toward colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact. Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs located in Boston, New York City, and Paris. For this position, candidates based in the United States are preferred to minimize logistical hurdles and maximize timezone overlap with colleagues and partners. What success looks like Lead and support the development of statistical analysis plans for clinical trials in collaboration with internal subject matter experts and external stakeholders. Perform power and sample size calculations that ensure our and our partners' studies are powered appropriately to measure meaningful effects on the brain. Deliver clear and impactful presentations and data visualizations to varied audiences, both internal and external. Lead and support the scientific and technical aspects of multiple concurrent studies, including timeline estimation, task delegation, timely execution, and stakeholder communication. Engage with external stakeholders to align their needs with internal capabilities and capacities to ensure analyses bring maximal value while remaining operationally feasible. Contribute to group-level processes and procedures to help make projects run more smoothly and efficiently. Co-author scientific reports whose impact pushes the field past contemporary limitations. Write and review reusable, documented, tested code that produces polished, high quality analytical results for our partners and powers our core computational pipelines. Leverage Beacon's products and your own subject matter expertise to inform analysis planning and execution. Dig into large, messy, unfamiliar datasets, document their idiosyncrasies and provenance, and harmonize them with Beacon's datastore. What you will bring You've spent multiple years in industry using your expertise in (frequentist) biostatistics to design and analyze clinical trials. You're deeply familiar with statistical modeling, including interpretation and diagnostics. You pick the right statistical tool for the job and, perhaps most importantly, you know when that tool is not a model. You have substantial experience presenting analyses to external audiences of varied backgrounds; you've learned the hard way what does and does not make an understandable and impactful presentation. You thrive in a fast-paced, highly customer-facing environment. You have experience writing and reviewing code in a shared, version-controlled codebase with multiple contributors and users. You write unit tests and documentation to ensure correctness and usability. You're painfully aware that thoughtful data curation is a prerequisite to analysis results that hold up under practical application. You love teamwork and recognize that people can achieve more together than individually. You value close collaboration, open communication, and tight feedback loops to ensure you and your team are working together effectively and doing your best work. You have excellent written and verbal communication and listening skills. You stay calm and organized to meet tight deadlines amidst ambiguity. You're familiar with and/or are excited to work with the technologies that power Beacon's data and reporting systems, including Julia, AWS, Superset, Pandoc, SQL, and GraphQL. You have exceptional attention to detail and maintain a high standard of quality in your work and output, but you also know when "quick and dirty" is the right approach. You're comfortable working in a highly asynchronous hybrid work environment, and have demonstrated success doing so in the past. We welcome applicants who are well established in their careers and those who bring senior-level expertise. The base salary range for this role is determined based on past experience, specific skills and qualifications. The base salary is one component of the total compensation package, which includes equity, PTO and other benefits. At Beacon, we've found that cultural and scientific impact is driven most by those that lead by example. As such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity. The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. Responsibilities: Leads the statistical programming activities for projects with lower complexity. Leads the statistical programming activities for studies. Develop SAS programs for the creation of ADaM data sets following CDISC standards. Develop SAS programs for the creation of Tables, Listings and Figures. Validation of ADaM data sets, Tables, Listings and Figures. Create specifications for the structure of ADaM data sets for individual studies and integrated data. Create documentation for regulatory filings including reviewers guides and data definition documents Leads the development of standard SAS Macros and participates in the development of standard operating procedures. Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts. **This is a US based remote position Qualifications MS in Statistics, Computer Science or a related field with 6+ years of relevant experience OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience. In-depth understanding of SAS programming concepts and techniques related to drug development. Fundamental understanding of CDISC Standards. Fundamental understanding of the drug development process, including experience with regulatory filings. Ability to communicate clearly both oral and written. Ability to accurately estimate effort required for study related programming activities. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************

Please no third party applicants A pharmaceutical company is looking for a Senior Biostatistician for a 6-month renewable project. This consultant must be very hands-on and have proven experience supporting regulatory submissions. In addition, they must possess strong programming skills (TLFs) and CDISC expertise. Strong communication is critical. EXPERIENCE & QUALIFICATIONS 8-10+ years of biostatistics experience in the pharmaceutical industry with recent Sponsor side experience Minimum of MS degree in Biostatistics/Statistics Must have recent hands-on statistical experience such as drafting SAPs and conducting programmatic TLF reviews Proven track record with regulatory submissions Ability to analyze data and provide guidance to the statistical programming team if needed Excellent communication skills to interpret and explain complex results to the study team LOCATION: Work will be performed remotely and prefer to accommodate PST core working hours.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle. This position leads a cross-functional, integrated quantitative team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs statistics, real-world evidence (RWE), safety/pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and advanced analytics. The role ensures consistency and scientific excellence across studies, indications, and evidence types-while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for solid tumor assets. **Responsibilities and Accountabilities:** Strategic Statistical Leadership + Serve as the compound-level statistical lead for solid tumor oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions. + Lead development of integrated statistical strategies across all relevant study types and functions (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). + Align statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs. Cross-Functional Quantitative Team Leadership + Lead and coordinate statistical and analytics contributions from a broad QSEG team, including: + Clinical trial biostatisticians + Exploratory oncology statisticians (e.g., tumor burden modeling, subgroup/signal detection) + Medical Affairs statisticians + Statistical programmers + Biomarker/statistical genetics experts in oncology + RWE analysts/statistical epidemiologists + Safety/PV statisticians + Advanced analytics and modeling specialists + Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. Regulatory and HTA Engagement + Represent Astellas on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). + Guide preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers. + Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Innovation and Methodological Excellence + Champion the use of oncology-appropriate innovations, including Bayesian designs, adaptive trial designs, external controls, tumor-agnostic approaches, and AI/ML tools to enhance study design and signal detection. + Promote exploratory data analysis, modeling, and simulation to support rapid development decisions in Solid Tumor trials. + Integrate clinical, biomarker, safety, and real-world evidence to drive cohesive, data-driven development and access strategies. Mentorship and Capability Development + Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career growth. + Share knowledge and best practices across study teams and therapeutic areas. + Contribute to internal training, methodology development, and talent pipeline initiatives. Governance and Cross-Functional Influence + Participate in global asset governance and development team meetings, influencing decisions with rigorous statistical insight. + Collaborate with Clinical Development, Medical Affairs, Regulatory, Market Access, and Commercial to ensure alignment on evidence planning. + Lead or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks. **Qualifications:** **Required** + PhD (or MSc with equivalent experience) in Biostatistics, Statistics, or a related quantitative discipline. + Minimum of 10 years of experience in oncology clinical development, with proven leadership in statistical strategy and regulatory submissions. + Demonstrated experience leading statistical contributions at the compound level, including regulatory engagement and cross-functional integration. + Broad expertise across clinical trial design, exploratory oncology analytics, biomarker evaluation, RWE, and post-marketing study support. + Broad expertise across clinical trial statistics, exploratory statistics, Medical Affairs statistics, biomarker statistics, safety/PV statistics, real-world evidence (RWE) analytics, and statistical programming. + Strong understanding of the drug development lifecycle, regulatory requirements, and evidence generation for both approval and market access. + Ability to lead and influence cross-functional, global teams within a matrix environment. + Strong communication, collaboration, and stakeholder engagement skills across both technical and non-technical audiences. + Proficiency in statistical software (e.g., SAS, R) and familiarity with simulation tools and modern statistical methods. **Preferred:** + Prior experience in oncology or other complex therapeutic areas with evolving clinical and regulatory landscapes. + Familiarity with Bayesian methods, adaptive designs, external control arms, and AI/ML applications in clinical development. + Prior experience with solid tumor basket/umbrella trials, tumor-agnostic strategies, and adaptive development pathways. + Familiarity with indirect comparisons, external controls, and payer analytics for oncology submissions. + Contributions to ASCO, ESMO, or other oncology-related publications or working groups. + Scientific contributions through publications, presentations, or participation in industry/regulatory working groups. + Experience working with real-world data sources, including data integration, study design, and interpretation. + Strong leadership presence and ability to represent the organization in regulatory, HTA, and scientific discussions externally. **Salary Range:** $170,450 - $267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Quantitative Sciences & Evidence Generation Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans