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Director, Biostatistics Medical Affairs

Employer
Regeneron Pharmaceuticals, Inc.
Location
Sleepy Hollow, New York
Start date
Nov 21, 2023

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Job Details

The Director of Biostatistics within Medical Analytics (Medical Affairs) is a leadership position within Medical Analytics and may have line management responsibilities. They may also have a statistical lead responsibilities for therapeutic area(s)/product(s) within Medical Affairs.

In this role, a typical day might include:

Working with Medical Affairs/Analytics leadership, they will help develop the overall strategy for Medical Analytics (Biostatistics) and work closely with Medical Analytics (Statistical Programming) to have an aligned strategy within Medical Analytics. 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 Analytics 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. They will need strong communication skills to interpret, explain, and discuss results of complex statistical analyses to both technical and non-technical colleagues. 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:

Overall

  • Leadership role within Medical Analytics (Biostatistics) to define departmental strategy, goals, objectives and may have line management responsibilities

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

Leadership and Management

  • Working with Medical Analytics leadership, help develop the overall strategy for the Medical Analytics (Biostatistics) group, work closely with Medical Analytics (Statistical Programming) to have an aligned strategy within Medical Analytics, and based on the strategy define departmental goals and objectives

  • Apply leadership techniques to promote teamwork, innovation, and motivation.

  • Estimate and plan for resource needs and allocation.

  • Working with Medical Analytics leadership, develop Medical Analytics policies and process improvement work streams (scientific, systems and process). Enforce and promote internal policies, systems, and processes.

  • Mentor and develop Medical Analytics staff.

Medical Analytics Departmental Initiatives

  • Develop 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.

Statistical Expertise in Study Design and Analysis

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

  • 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 (e.g., Phase IIIb/IV) including randomized studies, observational (non-randomized) studies, registries, non-interventional studies, cluster randomization, pragmatic clinical trials, etc.

Plan and Execute Statistical Analysis

  • 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.

Interpret Results and Communicate Conclusions

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

Teamwork

  • Develop strong partnerships within Regeneron, its partner organizations, and external experts and become established as a critical member of the team.

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

  • 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.

  • Experience promoting teamwork, innovation, and motivation.

  • Experience estimating and planning resource needs and allocation.

  • Experience promoting teamwork, innovation, and motivation.

  • Experience estimating and planning resource needs and allocation.

  • Knowledge of current statistical methods, at least 5 years using SAS to solve statistical problems, and experience with sample size calculation software (East, PASS, AddPlan, Nquery, etc.).

  • Minimum Years of Experience:

  • PhD in statistics/biostatistics/ epidemiology with at least 9 years of experience (or MS with at least 12 years of experience) in generating solutions to problems presented by medical and commercial personnel within the biopharmaceutical industry.

#GDBDMJobs

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)

$193,200.00 - $322,000.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Telephone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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