Sr. Manager, Statistical Programming
Senior Manager, Statistical Programming 1317513
Location: Watertown, MA (Hybrid)
Science/ Focus: Small Molecule
Therapeutic Area(s): Viral infections and liver diseases
Job Overview: The Sr. Manager, Statistical Programming will collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related disciplines, as well as external resources.
Responsibilities:
- Responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables.
- Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs.
- Develop/review TFL shells and SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
- Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
- Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives.
- Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
Qualifications:
- MS in related field (preferred)
- 5+ years of SAS programming experience in Biotech, Pharma, Clinical Research Organizations
- Experience in developing programming specifications for early and late phase clinical trials and regulatory submissions (IND, NDA, MAA).
- In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements.
- Experience working with / managing CROs and vendors
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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