Sr. Statistical Programmer
Sr. Statistical Programmer
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Salary Not Disclosed
1 Vacancy
Job Description
- 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.
- Bachelors 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.
Employment Type
Full-time
