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Nuvalent is a biotechnology research company developing precisely targeted therapies for patients with cancer. To do so, Nuvalent employs professionals across a
Associate Director, Statistical Programming
Location
Massachusetts
Posted
142 days ago
Salary
$180K - $210K / year
Seniority
Senior
Job Description
Associate Director, Statistical Programming
Nuvalent
• 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).
Job Requirements
- Master’s Degree in statistics, mathematics, computer science, or related scientific/medical field.
- 8+ years 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.
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