Biostatistics director job description

**ROLE SUMMARY**

The Director of Biostatistics will provide statistical leadership in one or more rare disease therapeutic areas (hematology, cardiology, nephrology, metabolic, or neurology), including oversight of pre-clinical and clinical development planning and execution for multiple indications in Pfizer's expanding Rare Disease Research Unit. The position will oversee coordination of statistical support efforts across numerous indications and therapeutic modalities (gene therapy, mRNA, small molecule, and biologics). In addition to accountability for the robust planning and execution of (pre-)clinical development programs, the Director will provide strategic leadership in relevant statistical areas such as external control matching, composite endpoint development, and other topics inherent in small-sample drug development.

**ROLE RESPONSIBILITIES**

+ Collaborate with various cross-functional scientists in the design, analysis and reporting of laboratory and early clinical studies in rare diseases

+ Provide statistical leadership in one or more therapeutic areas, including hematology, cardiology, nephrology, metabolic, or neurology

+ Core member of scientific teams responsible for determining strategy and delivering results in a timely and high-quality environment

+ Interact withinternal and external experts to assure sound quantitative approaches are applied to collection and analysis of a wide variety of data types

+ Leader to bring innovative statistical thinking and methods to help drive the Model Informed Drug Development paradigm within Pfizer. Central to this approach in the rare disease setting is the systematic review and incorporation of prior information (utilizing Bayesian methods as appropriate), statistical model building and simulation, and rigorous and robust use of external historical control data

+ Frequently interact and engage with regulatory agencies regarding accelerated clinical development options for indications that have substantial unmet medical need

+ Ensure rigorous approaches are taken to ensure good scientific practices are followed: excellent statistical methods utilized and documented in protocols, analysis plans and manuscripts, and assay methods are appropriately blinded, randomized and designed to meet clear objectives

+ Use statistical expertise to influence both internal and external reports and presentations, with the aim to improve the quality of internal decision making and increase our influence on the external environment

+ Mentor, train, and manage junior level staff

**QUALIFICATIONS**

+ MSc (PhD preferred) in Statistics, Biostatistics, or related field

+ Minimum of 8 years' experience applying statistical methods in the pharmaceutical industry, with early clinical (Phase I and Phase II) and translational experience in rare disease indications a definite advantage

+ Experience with modeling and simulation and expertise in Model Informed Drug Development (MIDD) principles

+ Demonstrated strong communication skills, both oral and written

+ Ability to proactively influence teams with innovative clinical development strategy

+ Demonstrated breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes, and create business impact

**OTHER JOB DETAILS**

Eligible for Relocation Package

Eligible for Employee Referral Bonus

\#LI-PFE

**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Medical

The Director, Biostatistics, provides statistical leadership in one or more indications, including support of clinical development planning and execution for multiple clinical trials. Performs statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical development team to determine protocol design. Evaluates databases and statistical analysis programs. Maintains expertise in state-of-the-art data statistical methodologies and statistical analyses. At the project level, the individual in this role ensures the study designs are scientifically sound and that the efficacy and safety endpoints meet regulatory requirements
This position can be based either in our Woburn office or be a remote role

+ + Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.

+ Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

Key responsibilities:

+ Provide statistical support to clinical development plan for multiple clinical trials

+ At study level, provide statistical input to study protocols, develop statistical analysis plan, and tables/listings/figures

+ Assist in writing relevant sections of the clinical study report and publications

+ Monitor and guide internal and CRO project activities including timelines, deliverables and resources

+ Participate in pre-IND and NDA/BLA activities

+ Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.

+ Develop and implement department standards and lead process improvements

Other Responsibilities:

+ Other duties as assigned

Education Requirements:

+ PhD or MS in Biostatistics or Statistics required

Experience and Skill Requirements:

+ At least seven (7) years' experience for PhD, or nine (9) years' experience for MS as statistician in the pharmaceutical or biotechnology industry.

+ Oncology (especially solid tumor) clinical trail experience preferred; knowledge of immuno-oncology is a plus.

+ Experience with advanced study design and up-to-date biostatistical methodologies.

+ Experience of NDA/BLA eCTDs or other global regulatory submissions. Experience of direct interaction with health authorities.

+ Experience as an independent lead statistician with responsibility for multiple studies or projects.

+ Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively.

+ Good knowledge of statistical programming languages (including SAS).

+ Knowledge of SDTM/ ADaM.

*Please note: Candidates must be local or open to relocating as remote is not an option for some roles.

Woburn Location: Local candidates are expected to be on-site 2 days per week. Non-local candidates open to 10-25% travel to Woburn office

Framingham Location: Please Note for Framingham roles 5 day onsite expectation

Replimune is an equal opportunity employer.

Replimune now requires COVID vaccination disclosure for all US employees


External Company Name: Replimune, Inc.

External Company URL: replimune.com

Street: 500 Unicorn Park Drive

Telecommute: Yes

Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Director, Biostatistics. This position will report to the VP of Biometrics and will work within Drug Development to lead statistical aspects of assigned projects and oversee the work of CROs. This role will partner with data management, statistical programming, clinical development, regulatory, clinical operations, medical affairs, clinical QA, research, and other functions, to develop content for Statistical Analysis Plans (SAPs), clinical and statistical requirements / execution, trial designs, protocol statistical sections, clinical development plans, sample size and power analysis, simulations, study reports, manuscripts, and regulatory submission documents.

Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezar's lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezar's first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is now being studied in a Phase 1 clinical trial in several oncology indications.
RESPONSIBILITIES:

Serve as the lead statistical expert on assigned project teams. Responsible for all statistical aspects of assigned clinical studies

Develop and review SAPs/TLF shells and statistical sections of protocols in collaboration with cross-functional teams, internal and external scientific leaders

Review and recommend clinical trial design options

Evaluate and negotiate the costs, resource needs, and timelines of various study scenarios and propose adjustments when necessary to protect timelines

Review and provide expert input for protocols, case report forms, data management plans, statistical power and sample size estimates, randomization schemes, clinical study reports, and regulatory submission documents

Validate / produce analyses in support of CSRs, scientific / conference presentations, publications, and regulatory submission needs

Work closely with internal / external statistical and programming resources; resolve statistical issues related to the interpretation of the planned / ad hoc statistical analyses

Oversee external vendors (CROs and statistical consultants) for assigned deliverables

Develop and review policies, SOPs, working instructions, and other controlled documents relating to Biometrics function

Support DMC requests in data review meetings, statistical analysis & programming needs

Other duties as assigned

COMMITMENTS:

Demonstrate strong commitment to support and achieve corporate / department goals and objectives

Represent the company by developing collaborative relationships with key opinion leaders, advisors, colleagues, and external vendors

Demonstrate professionalism and adherence to moral, ethical, and quality principles

Familiarity and compliance with applicable regulatory and ICH guidelines, FDA guidance documents, GCPs, corporate policies, and SOPs

REQUIREMENTS:

Ph.D. degree (preferred) in statistics, biostatistics, statistical science, data science, or related field

At least 7 years of experience focused on clinical trials in drug development in biotech, medical device, or pharmaceutical industry

Experience in early and late clinical development

Demonstrate technical excellence and strong presentation skills

Strong hands-on programming skills in SAS, R, Bayesian methods and simulations

Strong analytical and problem-solving skills

Familiar with innovative designs (adaptive and seamless Ph2/Ph3) and sample size re-estimation

Detail-oriented and accurate; self-initiative, good written and oral communication skills, and strong scientific curiosity are essential

In-depth knowledge and familiarity with CDISC standards, requirements, SDTM and ADaM datasets, and supporting documents in regulatory submissions

Ability to manage multiple and complex projects simultaneously and adjust quickly based on company / departmental needs

Ability to think creatively, articulate sound opinions, and make good decisions in a dynamic environment

Solid organizational, time management, and collaborative skills with the ability to effectively manage ad hoc requests

Experience in auto-immune disease and oncology therapeutic areas is desirable but not required

Kezar Life Sciences is an Equal Opportunity Employer