About the job
The Company:
Nuvalent is a pioneering organization with profound expertise in chemistry, dedicated to developing selective therapeutics aimed at addressing the needs of cancer patients. As an innovative early-stage company, Nuvalent unites seasoned scientists and industry veterans, boasting a successful history in drug discovery, oncology drug development, and corporate advancement.
The Role:
As the Associate Director of Statistical Programming, you will report directly to the Senior Director of Statistical Programming. Your primary responsibility will be to execute statistical analyses utilizing SAS while ensuring the quality and accuracy of SAS programs and outputs for both in-house analyses and outsourced programming efforts. You will also conduct programming analyses to fulfill ad-hoc requests for publications and presentations.
This remote role will involve close collaboration with various departments, including Biostatistics, Data Management, Clinical Operations, Regulatory Affairs, Global Pharmacovigilance, and other related fields, as well as with Contract Research Organizations (CROs).
Key Responsibilities:
- Serve as the lead programmer to create and/or validate tables, listings, figures, and analysis datasets in response to regulatory and publication requests, as well as ad-hoc analyses; document programming specifications.
- Develop and review TFL shells, SDTM, and ADaM specifications in partnership with biostatisticians and clinical development colleagues.
- Collaborate closely with Data Management and Biostatistics to ensure accuracy in final databases, analyses, and reports.
- Oversee or collaborate with CROs or programming vendors to execute the aforementioned tasks.
- Ensure proper collection, management, and documentation of clinical trial data in compliance with regulatory standards.
- Manage project timelines and schedules for specific project phases while collaborating with both internal personnel and external stakeholders.
- Identify challenges and create global tools to enhance the efficiency and capacity of the Statistical Programming team (e.g., macros or graphical user interface applications).

