Principal biostatistician job description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.
We do things differently than large CROs and would love to have you join our Veristat team!

The Principal Biostatistician provides statistical input into Phase I - IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. The Principal Biostatistician can work independently and function as a lead statistician on clinical trials.


As a Principal Biostatistician you will...


Providing statistical input into protocol and case report form (CRF) development in all therapeutic areas (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, edit checks for clinical trial data) Communicating with clients regarding study protocol or statistical analysis issues; and writing detailed statistical analysis plans including specifications for analysis files, consistency checks, tables, and figures. Consult and communicate with clients one-on-one on study designs and statistical consulting concepts including, but not limited to, interim analysis designs, sample size calculations and re-estimations, etc. Interact with various regulatory agencies on behalf of clients. Analyzes clinical trial data producing accurate results representing the outcome of the trial, validates statistical output, accurately interprets and clearly communicates statistical results and concepts to non-statisticians. With the medical writer, co-authors final integrated reports of clinical trial data by writing thorough and clear statistical methods sections and producing the statistical appendix for the final report. Provides statistical output as required for manuscripts and ensure that the results are accurately interpreted in the publications. Provides input into statistical standard operating procedures (SOPs) and general standardization efforts (e.g., statistical methodology standards, standard data presentations) and participates in interactions with regulatory agencies, as required. Collaborates effectively with members of clinical trial implementation teams and with Biometrics colleagues, and keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.


Experience & Minimum Requirements:


PhD degree in Statistics, Biostatistics, or related field, and 5 years of biostatistical experience in the clinical trials or health research environment OR a Master's degree in Statistics, Biostatistics, or related field, and 8 years of biostatistical experience in the clinical trials or health research environment. Excellent written and oral communication skills including grammatical/technical writing skills and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required. Familiarity with SAS, SPSS or other statistical software package. Proficiency in Microsoft Word and Excel. Strong level of detail orientation. Ability to work on multiple tasks under tight timelines.


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Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision making process.

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development.
As a Principal Biostatistician, a typical day might include:

Working with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.

They will co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports. They will also develop and deliver training to non-statistical colleagues, collaborate on development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications.

This role might be for you if you can:

Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Pre-clinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials. Develops individual protocols and statistical analysis plans and determines appropriate statistical methodology for data analysis. Collaborates with Statistical Programming on the programming of tables, figures and listings to support decision making and for regulatory reporting. Evaluates appropriateness of available software for planned analyses and resolves needs for use of novel statistical methodology or tools. Analyzes data and interprets results from clinical trials and of data from non-trial sources to facilitate program-level decision making. Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management. Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.



To be considered for this opportunity, you must have the following:


PhD or equivalent degree in statistics/biostatistics or related fields with internship experience, or MS degree in statistics/biostatistics with >4 years' experience in the pharmaceutical industry as a statistician. Excellent influence and leadership skills, and a proven track record to collaborate in a cross-functional environment. Work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills. Proven knowledge of statistical analysis methodologies, experimental and clinical trial design Expertise in statistical software such as R or SAS is required


Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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About this role

As the Senior Principal Biostatistician, you are responsible for leading study design and data analysis and providing the statistical expertise for company products within one or more therapeutic areas in clinical development, biomarker development, research, Biotherapeutic and Medicinal Sciences (BTMS) or Pharmaceutical Operations & Technology (PO&T). You act as independent Study Management Team (SMT) or Research and Development Project Team (RDPT) Biostatistician, provide statistical input in the scientific discussion, participate in protocol development, analysis plans and file/report specifications, and review study setup activities including but not limited to randomization, Case Report Forms (CRFs) and serve as lead biostatistician assigned project(s). You perform statistical analyses, interpret statistical results, and prepare clinical study reports including integrated summaries for submissions as appropriate. You also assist in preparation of responses to statistical issues arising in regulatory or other legal settings, or from external development partners. You maintain liaison with clinical research personnel in order to identify and meet the statistical support required by the development strategy under the supervision of the Associate Director or Director. You also contribute to the long-term growth strategy of the department by participating in process improvement initiatives, keeping abreast of the current statistical methodology development, and providing mentorship to new/junior biostatisticians.

What you'll do

Represent Biostatistics on Project or Study Teams; provides statistical expertise to support clinical, discovery, research, biomarker development, objectives and strategy.

Define statistical methodology, analyzes data and reports results and contributes to the strategic planning and execution of the clinical development plan for the assigned project; trains and supervises contract statisticians and ensures the quality of their deliverables.

Assist responses to addressing statistical issues are part of regulatory, legal, or other challenges to the company's products or processes; may represent Biostatistics in key meetings as assigned

Serve as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel, and acts as an internal consultant, as assigned, on broad statistical issues that impact on the pharmaceutical/Biotechnology industry

Participate in approved process improvement initiatives; mentors new/junior biostatisticians; keeps up to date current on statistical methodology and computing development. Conducts modelling and simulations as needed

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