Nuvalent, Inc.

Associate Director, Statistical Programming

Nuvalent, Inc.

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Salary

💰 $180,000 - $210,000 per year

Job Level

Senior

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAS programmingMacro languageBASE SASSAS/STATSAS/GRAPHCDISC SDTMCDISC ADaMstatistical programmingdata validationquality control
Soft Skills
project managementcollaborationproblem solvingcommunicationleadership
Certifications
Master’s Degree in statisticsMaster’s Degree in mathematicsMaster’s Degree in computer science