Medical Analytics Contractor (Statistical Programming)
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.
The Contractor (Statistical Programming) supporting Medical Analytics within Medical Affairs will be responsible for the statistical programming aspects and deliverables for product(s)/project(s) in regards to Medical Affairs activities with guidance and/or direct supervision from senior Medical Analytics colleagues.
Together with Medical Analytics (Biostatistics), Medical Affairs and HEOR colleagues, he/she will plan and execute statistical analysis, provide input into and align with the publications plan, and support Medical Affairs/HEOR analysis needs. He/she will need strong communication skills to understand the research question, implement complex statistical analyses, and explain analysis implementation (in particular, details regarding the specific analysis implementation, definitions and/or output generation).
Serve as the statistical programmer for product(s)/project(s) with guidance and/or direct supervision from senior Medical Analytics colleagues.
Plan and Execute Statistical Analysis
- Author parts of and/or provide significant input into the Statistical Analysis Plan (SAP) to comprehensively and unambiguously define the statistical analysis specifications, data derivations, and display shells to be generated in collaboration with key stakeholders.
- Perform 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/validation and active review for completeness and accuracy (including developing and implementing a well documented validation plan).
- Understand ICH, GCP and health authority guidelines with regard to reporting and associated regulations and standards (including CDISC standards).
Statistical Programming Experience
- Experience in statistical programming 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).
- Expert proficiency in SAS/STAT modules that support linear models, categorical data, and time-to-event data.
- Familiarity with SAS high-resolution graphics to supplement aforementioned statistical models.
- Ability to make use of standard macros or author specialized limited-use macros.
- Experience in statistical programming methods to support Health Economics and Outcomes Research including analysis related to patient reported outcomes (including development/validation) and HTA/reimbursement/value dossiers, and real world studies (for example, registries).
Teamwork and Communication
- Strong communication skills to understand/document the SAP requirements and explain/discuss implementation details of complex statistical analyses to both technical and non-technical audiences
Experience in executing statistical analysis by authoring parts of and/or providing significant input in the SAP, implementing the SAP using SAS, ensuring quality via validation, and explaining implementation details to technical and non-technical audiences.
Experience in statistical programming methods as it relates to the following areas:
- Medical Affairs analyses using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials).
- Health Economics and Outcomes Research analyses including analysis related to patient reported outcomes (including development/validation), HTA/reimbursement/value dossiers, and real world studies.
- MS/PhD in statistics/ mathematics/ engineering/computer science/life sciences or related discipline with at least 3 years of experience in statistical programming using SAS in the biotechnology, pharmaceutical or health related industries.
- MS/PhD in statistics/mathematics/engineering/computer science/life sciences or related discipline (see Educational Requirements/Experience for more information)
- Expert knowledge of statistical programming methods using SAS to solve statistical problems.
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.
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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.