Associate Director, Biostatistics Medical Affairs

The Associate Director (Biostatistics) within Medical Affairs is a leadership position providing statistical lead responsibilities for therapeutic area(s)/product(s).

In this role, a typical day might include:

Working with the Medical Affairs leadership within Biostatistics, they will help develop the overall strategy for Biostatistics Medical Affairs and work closely with Statistical Programming to have an aligned strategy within Medical Affairs.  They will contribute to setting the departmental goals and objectives, learn and apply leadership principles to promote teamwork, innovation and motivation, and provide input into future resource needs and allocation.  They will provide significant input into and promote the use of Medical Affairs policies and process improvement work streams (scientific, systems and process).

Together with Medical Affairs and HEOR colleagues, they will provide strategic guidance for therapeutic area(s)/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 publications plan, and support HEOR studies intended for payer and reimbursement needs.

This role might be for you if have previous experience including:

• Senior role within the Biostatistics Medical Affairs group to define departmental strategy, goals, objectives.

• Serve as the statistical lead for therapeutic area(s)/product(s) within Medical Affair

• Develop standards within Medical Affairs including statistical position papers, standard analysis/display catalogues, and SAS macro libraries.

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

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

• 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.

• 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 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.

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).

• Expertise in statistical methods to support Health Economics and Outcomes Research including patient reported outcomes (including development/validation), 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, at least 5 years using SAS or R to solve statistical problems, and experience with sample size calculation software (East, PASS, AddPlan, Nquery, etc.).

• PhD in statistics/biostatistics/ epidemiology with at least 7 years of experience (or MS with at least 10 years of experience) in generating solutions to problems presented by medical and commercial personnel within the biopharmaceutical industry.

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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)

$165,900.00 - $270,700.00