Associate Director, Statistical Programming jobs in United States
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Nuvalent, Inc. · 7 hours ago

Associate Director, Statistical Programming

Nuvalent is an early-stage company focused on creating selective medicines for cancer patients. The Associate Director, Statistical Programming will lead statistical analyses using SAS, ensuring quality and accuracy in programming deliverables and collaborating with various departments and CROs.

BiotechnologyLife ScienceTherapeutics

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)

Qualification

SAS programmingCDISC SDTMCDISC ADaMRegulatory guidelinesStatistical conceptsOncology experienceCommunicationProblem solvingRelationship buildingOrganizational skills

Required

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

Company

Nuvalent, Inc.

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Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets.

Funding

Current Stage
Public Company
Total Funding
$1.82B
Key Investors
Bain Capital Life SciencesDeerfield
2025-11-18Post Ipo Secondary· $500M
2024-09-16Post Ipo Equity· $575M
2023-10-16Post Ipo Equity· $300M

Leadership Team

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James Porter
CEO
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Alexandra Balcom
Chief Financial Officer
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Company data provided by crunchbase