Sr. Statistical Programmer

1 week ago

Lake Bluff, IL, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • The Sr. Statistical Programmer supports the Biostatistics team in the generation and validation of analysis datasets and statistical outputs for clinical trials.
  • This role is key to implementing programming standards and supporting the standardization of CDISC-compliant datasets (e.g., SDTM, ADaM) across clinical programs.
  • Develop and validate SAS programs to generate analysis datasets, tables, listings, and figures (TLFs) that support clinical trial reporting, regulatory submissions, and publications.
  • Implement and maintain standardized programming templates, macros, and tools to ensure consistency, efficiency, and compliance across clinical studies.
  • Contribute to the creation and review of programming specifications for SDTM and ADaM like datasets based on CDISC standards and internal guidelines.
  • ssist in programming support for data cleaning, interim analyses, medical review, and final study reports.
  • Collaborate with statisticians, data managers, clinical team members, and external vendors to ensure timely and high-quality deliverables.
  • Review Statistical Analysis Plans (SAP) with biostatisticians to anticipate any complications or complexities for programming activities.
  • Perform quality control (QC) and validation of internally and externally developed datasets and outputs, adhering to company SOPs and programming best practices.
  • Integrate data across multiple studies for pooled analyses, submission packages, or visual summaries to support regulatory filings or internal strategy.
  • Document all programming activities clearly and thoroughly, supporting reproducibility and regulatory compliance in a validated programming environment.
  • Use version control systems and structured documentation to support audit readiness and collaborative programming practices.
  • Contribute to posters, presentations, or ad hoc analyses, including visual data summaries using SAS graphics or other data visualization tools.
Requirements:
  • Bachelor's degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline.
  • 5+ years of experience in statistical programming within the pharmaceutical, biotechnology, or medical device industry.
  • Understanding of clinical trial design, GxP principles, and FDA/EMA regulatory requirements, particularly for medical device submissions such as PMA and 510(k).
  • The ideal candidate is a detail-oriented statistical programmer with a strong interest in clinical data analysis, regulatory processes (such as PMA or 510(k) submissions), and continual learning in a regulated environment.
  • Familiarity with CDISC standards (SDTM, ADaM); ability to implement standardized datasets in line with internal and industry guidelines.
  • Strong attention to detail, problem-solving mindset, and ability to work independently or in a team environment.
  • Effective communication skills and a collaborative approach to working with cross-functional teams.

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