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 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.

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