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Senior Manager, Biostatistics Medical Affairs

  • Sleepy Hollow, New York, United States of America / Basking Ridge, New Jersey, United States of America
  • Global Development
  • R25276

Job Description

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The Senior Manager of Biostatistics Medical Analytics will be responsible for product and indication within Medical Affairs.

In this role, a typical day might include:

As part of a collaborative Medical Analytics team, you will implement the overall strategy for the Medical Analytics (Biostatistics) group. You will be responsible for following departmental guidelines promoting teamwork, innovation, and motivation. They will provide feedback into, and promote the use of, Medical Analytics policies and process improvement work streams (scientific, systems and processes). Together with Medical Affairs and HEOR colleagues, they will provide strategic guidance for product(s) to LCM/HEOR/Publications strategy, define future research questions, plan and execute statistical analysis, provide input into Medical Affairs lifecycle management strategy and tactics, provide input into and align with the publication plan, and support HEOR studies intended for payer and reimbursement needs. Working in a dynamic team with a wide range of interfaces, the role requires both strategic and operational skills combining innovative statistical thinking with a strong sense of business acumen.

This role might be for you if have:

  • Worked with Medical Analytics leadership to implement and execute departmental strategy/goals/objectives.

  • Serve as the statistical lead for product(s)/indication(s) within Medical Affairs with minimal guidance from senior Medical Analytics colleague(s).

  • Statistical Expertise in Study Design and Analysis

  • Provides scientific/statistical input into research study design, formulates novel methods to problem solving, and independently develop the statistical analysis plan to implement those solutions.

  • Author the Statistical Analysis Plan (SAP) to define the appropriate statistical analyses to address research questions, specifications for data derivation, specifications for the statistical analysis methodology, and the display shells for the outputs to be generated in collaboration with key stakeholders.

  • Perform and/or oversee statistical analyses using SAS to generate tables, listings, and figures for use in publications/presentations and for internal purposes.

  • Ensures quality of deliverables through appropriate testing and active review for completeness and accuracy including oversight of work packages outsourced to CROs (including developing and implementing an oversight plan).

  • Maintain up-to-date with state-of-the-art statistical science by participating in scientific societies, constant review of the clinical and statistical literature, and translate and apply relevant innovative statistical methodology to everyday work.

  • Strong communication skills to interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical audiences.

  • Provide substantial input into standards within Medical Analytics including statistical position papers, standard analysis/display catalogues, and SAS macro libraries.

  • Further the technology, systems, and process infrastructure within Medical Analytics.

  • Educate and disseminate knowledge throughout the organization for areas within the expertise of Medical Analytics.

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

  • Expertise in statistical methods to support Medical Affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials). Past experience in Oncology/Hematology is highly desired

  • Experience in statistical methods to support Health Economics and Outcomes Research including meta-analysis (including Bayesian network meta-analysis), patient reported outcomes (including development/validation), and HTA/reimbursement/value dossiers, and real world studies.

  • Expertise in statistical methods to support new studies including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, pragmatic clinical trials, etc.

  • Knowledge of current statistical methods, >4 years using SAS to solve statistical problems, and experience with sample size calculation software (East, PASS, AddPlan, Nquery, etc.).

  • PhD in statistics/biostatistics/epidemiology with >4 years of experience (or MS with 7-8 years of experience or more) in generating solutions to problems presented by medical and commercial personnel within the biopharmaceutical industry.


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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$141,800.00 - $231,400.00