Nuvalent, Inc.
11 - 50 employees
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
Nuvalent, Inc. is a biotechnology company focused on developing targeted therapies for patients with cancer. With a strong foundation in chemistry and structure-based drug discovery, Nuvalent designs innovative small molecules to effectively inhibit kinase targets, overcoming challenges of resistance and selectivity. The company collaborates with physician-scientists to address patient needs and limitations of existing therapies, ensuring their solutions are built for patients and driven by a deep sense of purpose. Nuvalent is committed to using their expertise to deliver precisely targeted cancer treatments.
Associate Director, Statistical Programming
🕒 January 30
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Nuvalent, Inc.
11 - 50 employees
🧬 Biotechnology
💊 Pharmaceuticals
Biotechnology • Pharmaceuticals
Nuvalent, Inc. is a biotechnology company focused on developing targeted therapies for patients with cancer. With a strong foundation in chemistry and structure-based drug discovery, Nuvalent designs innovative small molecules to effectively inhibit kinase targets, overcoming challenges of resistance and selectivity. The company collaborates with physician-scientists to address patient needs and limitations of existing therapies, ensuring their solutions are built for patients and driven by a deep sense of purpose. Nuvalent is committed to using their expertise to deliver precisely targeted cancer treatments.
📋 Description
• 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).
🎯 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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