Director, Epidemiology Analytics
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.
Incumbent will be accountable for setting up the analytic capability and leading statistical and analytical activities in support of pharmacoepi (PE) projects using internal or external automated healthcare databases or registries. He/she is expected to work with internal and external cross-functional project leaders and real-world data (RWD) partners to establish data sources, queries, and framework for the conduct of a wide variety of non-interventional studies; coauthor/author study protocols and SAPs; conduct statistical analysis, programming, and consultation to provide real word evidence (RWE) in support of clinical development, regulatory filings, commercialization, and research at RGC; secure IT solutions for the data transfer, storage, management & maintenance for PE projects.
Essential Functions required for the job. List both technical and managerial requirements if applicable.
With oversight from Head of Pharmacoepidemiology:
1. Set up the analytic capability and leading statistical and analytical activities in support of pharmacoepi (PE) projects such as Postmarket Requirements and Commitments (PMRs/PMCs), Post-Authorization Safety Studies (PASS), Post-Authorization Efficacy Studies (PAES), effectiveness studies of Risk Evaluation and Mitigation Strategy (REMS) or Risk Minimization Measures (RMMs), Drug Utilization Studies (DUS), Post-marketing Surveillance (PMS) studies, and ethnicity sensitivity analyses using internal or external automated healthcare databases or registries
2. Work closely with internal and external cross-functional project leaders and real-world data (RWD) partners in Pharmacovigilance, Risk Management, Regulatory Affairs, Biostatistics and Data Management, Regeneron Genetic Center (RGC), Clinical Development, Medical affairs, and Health Economic Outcome Research (HEOR) etc to establish data sources, queries, and framework for the conduct of a wide variety of non-interventional studies
3. Coauthor/author study protocols and SAPs; review the protocols and SAPs of the partnered studies
4. Conduct statistical analysis, programming, and consultation to provide real word evidence (RWE) in support of clinical development, regulatory filings, commercialization, and research at RGC
5. Provide consulting service and support to the cross-functional team on collaborative projects including assisting in the development of protocols, and completion analyses on unmet medical needs, patient population for clinical trials, natural history of diseases, comparative effectiveness analyses, quantitative signal detection and evaluation, and benefit risk assessment etc
6. As a SME in epidemiology analytics, oversee and manage requests for statistical analysis and programming activities according to study protocols within the research area
7. Serve as the primary contact and source for epidemiology analytics for descriptive and analytical epidemiologic research within a global team
- Leadership and ability to proactively develop and foster constructive interactions among team members
- Up-to-date knowledge of US, EU, and international regulatory and pharmacovigilance requirements and ability to apply this knowledge to activities for clinical trial and post-marketing environments.
- Excellent interpersonal and communication skills
- High ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self) under pressure
- Self-motivation, initiative and attention to detail
- Excellent skills with SAS, R, Python (other programming languages), STAT, GRAPH, SQL and Macros
- A Doctoral degree and excellent knowledge in quantitative fields (e.g. statistics, computer-science, biostatistics, mathematics, epidemiology)
- Major of biostatistics/statistics is preferred
- 7+ years post-doctoral experience with statistical analysis, SAS programming, database management, and system support of automatic healthcare databases
- 5+ years experience in big data of insurance claims, electronic medical records or other longitudinal databases) in the pharmaceutical industry or related areas (Epidemiology, Biostatistics, or Outcome Research) highly desirable
- 3+ years experience working with external vendors
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.