Ecocareers · 3 months ago
Sr. SAS Programmer
Confidential company is seeking a highly skilled Senior Statistical Programmer to join their growing Biometrics team. The ideal candidate will be responsible for providing advanced programming support for the analysis and reporting of clinical trial data in compliance with regulatory requirements.
Staffing & Recruiting
Responsibilities
Develop, validate, and maintain SAS programs to generate analysis datasets (ADaM, SDTM) and TLFs for clinical trial submissions
Ensure programming deliverables are accurate, efficient, and compliant with CDISC standards and regulatory guidelines
Collaborate with Biostatistics and Data Management teams to understand study requirements and timelines
Participate in the development of programming standards, macros, and process improvements
Provide mentorship and guidance to junior programmers and review their work for quality and accuracy
Support regulatory submissions (FDA, EMA, PMDA) by preparing submission-ready datasets and documentation
Troubleshoot and resolve complex programming issues independently
Qualification
Required
Bachelor's or master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field
5+ years of experience as a Statistical Programmer in the pharmaceutical, biotechnology, or CRO industry
Strong proficiency in SAS programming; knowledge of R or other statistical software is a plus
In-depth knowledge of CDISC SDTM and Adam standards
Experience supporting Phase I–IV clinical trials and regulatory submissions
Excellent problem-solving, communication, and organizational skills
Ability to work both independently and in a team-oriented environment
Experience with eCTD submissions and regulatory agency interactions
Familiarity with oncology, rare disease, or other therapeutic areas
Knowledge of data visualization tools (e.g., R Shiny, Spotfire)
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
Funding
Current Stage
Early StageCompany data provided by crunchbase