Associate Director - Director, Statistical Programming

4 days ago

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Nuvalent, Inc.

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Description

• With deep expertise in chemistry, Nuvalent is working to create selective medicines designed with the goal to address the needs of patients with cancer. • 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. • 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.

Requirements

• Master’s Degree in statistics, mathematics, computer science, or related scientific/medical field. • 8+ years (director level 12+) of (SAS) statistical programming experience in a clinical trial setting (industry/CRO). • Advanced SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures. • Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards. • In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials. • Familiar with regulatory guidelines (FDA, EMA, ICH) related to clinical trials, statistics and data handling in clinical development setting, and advanced knowledge of submission requirements and standards. • Experience with outsourcing programming activities and overseeing services provided by CROs and contractors. • Advanced understanding of statistical concepts in support of clinical data analysis. • Advanced knowledge of programming standards and processes. • Oncology experience is required. • Skilled at performing quality control checks of SAS code and outputs produced by other Statistical Programmers.