Bachelor's degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
5+ years of experience in statistical programming within pharma, biotech, or medical device industries.
Detail-oriented with a strong interest in clinical data analysis and regulatory processes.
Understanding of clinical trial design, GxP principles, and FDA/EMA requirements for medical device submissions.
Familiarity with CDISC standards (SDTM, ADaM) and ability to implement them.
Strong attention to detail and problem-solving skills, able to work independently or collaboratively.
Effective communication skills for cross-functional team collaboration.
Responsibilities
Support Biostatistics team in generating and validating analysis datasets and statistical outputs for clinical trials.
Implement programming standards and support standardization of CDISC-compliant datasets across clinical programs.
Develop and validate SAS programs for analysis datasets and key reports.
Maintain standardized templates, macros, and tools for consistency and compliance in studies.
Contribute to programming specifications for SDTM and ADaM datasets based on CDISC standards.
Assist with programming for data cleaning, interim analyses, and final reports.
Collaborate with cross-functional teams to ensure timely, quality deliverables.
Perform quality control and validation of datasets and outputs according to SOPs.
Benefits
Health, dental, and vision insurance coverage.
Retirement savings plan with company match.
Generous paid time off and holiday schedule.
Opportunities for professional development and training.
Support for continuing education and certification.
Full 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 (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
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.
