KH
Senior Statistical Programmer
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Senior
- 10 months ago
- CDISC
- SAS
- SAP
- Regulatory Compliance
- Data Visualization
- GxP
10 months ago
- 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
- 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.
- 5+ 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 510(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 510(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.
Senior Statistical Programmer · Katalyst Healthcares & Life Sciences