What are the responsibilities and job description for the Associate Director / Director, Statistical Programming position at Nuvalent, Inc.?
The Company : With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. Nuvalent is an exciting early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
The Role :
Reporting to the Senior Director, Statistical Programming, the Associate Director / Director, Statistical Programming will be 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. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations.
This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related disciplines, as well as CROs.
Responsibilities :
- 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, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
- Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.
- Partner with or oversee CROs or Programming vendors to perform the tasks described above.
- Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
- Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives.
- Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).
Competencies Include :
Qualifications :
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