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Senior Statistical Programmer
Senior Statistical ProgrammerKatalyst HealthCares & Life Sciences • Los Angeles, CA
Senior Statistical Programmer

Senior Statistical Programmer

Katalyst HealthCares & Life Sciences • Los Angeles, CA
30+ days ago
Job type
  • Temporary
Job description

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 (, 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
  • Assist 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
  • Other duties as required

Requirements:
  • Bachelor's degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline.
  • + years of experience in statistical programming within the pharmaceutical, biotechnology, or medical device industry.
  • Candidate is a detail-oriented statistical programmer with a strong interest in clinical data analysis, regulatory processes (such as PMA or (k) submissions), and continual learning in a regulated environment.
  • Understanding of clinical trial design, GxP principles, and FDA/EMA regulatory requirements, particularly for medical device submissions such as PMA and (k).
  • 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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Senior Statistical Programmer • Los Angeles, CA

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