Manager, Biostatistician - Oncology:
Regeneron Pharmaceuticals, Inc.

894073264
Regeneron Pharmaceuticals, Inc.
Tarrytown New York
Pharmacy
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Description
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.
Job Duties:
• With occasional supervision and guidance from senior departmental staff, provide support to a clinical study team and strategic project team on all relevant statistical matters. Working directly with the medical directors and other study personnel, act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis. Defend design at management forums (DPR and PRC).
• With limited supervision and guidance from senior departmental staff, contribute to design of a clinical study and help draft protocols or amendments. Perform relevant sample size calculations.
• Develop statistical analysis plan (SAP). Perform analyses and author statistical methods and results sections of the clinical study report (CSR). Provide statistical insight into interpretation and discussion of study results. Contributes tables and figures for management presentations.
• Under limited supervision and guidance of experienced statisticians, contributes to clinical trial teams. Attends GCST and SPT on straightforward programs to represent department.
• Independently prepares TFLs to support CSRs, DSURs, IB and other documents. Collaborates with Medical Writing and Clinical to ensure tables are complete. Supports TFL production for ISE/ISS for submissions. Contributes to regulatory submissions.
• Under limited guidance of senior staff, supports preparation of material to be used in regulatory interactions, including drafting analysis plan under supervision/guidance and production of TFLs to be used in regulatory meetings, slides for ACMs, etc.
• Contributes to authoring of regulatory background packages, including those for pre-IND, EOP2, and pre-BLA meetings. Will contribute background material for ACMs and perform additional analyses as required for labeling negotiations. Attends pre-IND, EOP2, and pre-BLA meetings with experienced statistician.
• Contributes to technical working groups by developing new methodology and conducting simulation studies under the supervision of senior departmental staff. Contributes to revising SOPs as appropriate

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Basic Qualifications
Requirement