Senior Manager, Medical Analytics (Biostatistics)

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
Our medical affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional area expertise.
The Associate Director (Biostatistics) within Medical Analytics is a leadership role within Medical Analytics and may have line management responsibilities. He/she will also have statistical lead responsibilities for indication(s)/product(s) within Medical Affairs.

The Senior Manager (Biostatistics) within Medical Analytics will be the statistical lead responsible for all statistical aspects and deliverables for product(s)/project(s) in regards to Medical Affairs activities.

Together with Medical Affairs and HEOR colleagues, he/she will 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. He/she 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.

Overall:
Serve as the statistical lead for product(s)/project(s) within Medical Affairs.

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 meta-analysis (including Bayesian network meta-analysis), patient reported outcomes (including development/validation), studies using external databases (e.g., claims, EMR, etc.), 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.

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.

Expertise in 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 meta-analysis (including Bayesian network meta-analysis), patient reported outcomes (including development/validation), studies using external databases (claims, EMR), 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.

Education/Training:

• PhD in statistics/biostatistics/ epidemiology with at least 3 years of experience (or MS with at least 6 years of experience) in generating solutions to problems presented by medical and commercial personnel within the biopharmaceutical industry.
• 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.).

Expertise in 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 meta-analysis (including Bayesian network meta-analysis), patient reported outcomes (including development/validation), studies using external databases (claims, EMR), 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.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

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