Manager, Statistical Programming

Regenxbio-posted 3 months ago
Full-time • Mid Level
Rockville, MD
251-500 employees
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As the Manager, Statistical Programming, you will be responsible for supporting Statistical Programming efforts for clinical trials at REGENXBIO. Additionally, your responsibilities will include primary and/or Quality Control (QC) SAS programming for assigned clinical trials, and providing oversight and Quality Assurance (QA) of outsourced work at a Clinical Research Organization (CRO).

  • Contributes to day-to-day statistical programming activities in support of ongoing projects
  • Develops SAS outputs as necessary to support data management and clinical review of data
  • Develops and/or validates SAS programs to generate SDTM/ADaM datasets following industry standards, regulatory requirements, and statistical instructions
  • Develops and/or validates SAS programs to generate statistical output (e.g. TLFs) of clinical trial data as specified in the Statistical Analysis Plan (SAP), as required for regulatory and safety review reasons (i.e. DSUR or IDMC deliverables), and for ad hoc analysis as requested
  • Documents data and programming information in accordance with SOPs, guidelines and industry standards
  • Collaborates with team members to help track timelines for statistical programming activities
  • Assists in the development and maintenance of derived dataset specifications, programming specifications, and other supporting documents
  • Develops SAS macros, templates and utilities for reporting and data cleaning
  • Provides oversight to Contract Research Organizations (CROs)
  • Develops and tests SAS codes for clinical trial database logic checks
  • Works closely with senior programmers and statisticians to learn best practices and contribute to team deliverables
  • Minimum of Bachelor’s Degree; Bachelor’s Degree in Computer Science, Statistics, Mathematics, or a scientific discipline preferred
  • SAS programming at an intermediate level
  • Minimum 3 years of experience in statistical programming in a clinical trial environment
  • Understanding of the drug development process and the functions and roles in a Pharmaceutical/Biotech clinical organization
  • Strong knowledge of regulatory requirements as related to statistical programming (e.g., CDISC standards, 21 CFR Part 11, FDA requirements, electronic submission standards, etc.)
  • Foundational knowledge of concepts related to statistical programming (e.g., coding dictionaries, annual reporting, EDC systems, etc.)
  • Outstanding verbal and written communication skills
  • Ability to effectively manage timelines and priorities
  • Ability to build successful relationships and interact at the study team level
  • Market-competitive salaries
  • Annual bonus program
  • Education assistance
  • Retirement plan with employer match
  • Stock options at all levels
  • Summer hours
  • Access to development resources for personal and professional growth
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