Principal Statistical Programmer

Job highlights

• Bachelors Degree or Masters degree in Computer Science,Statistics,Mathematics,Life Sciences,or related field. . 7-9 years in statistical programming within the pharmaceutical,biotech,or CRO industry.
• In depth experience with CDISC SDTM and ADaM standards.

Job Summary

The Principal Statistical Programmer is a senior-level contributor responsible for designing, developing, validating, and maintaining statistical programming deliverables to support clinical trials and regulatory submissions. This individual serves as a technical expert on study and project teams, providing leadership in the application of statistical programming standards and regulatory guidance (e.g., CDISC, ICH, FDA).

Responsibilities

• Lead the development, validation, and maintenance of SDTM and ADaM datasets and associated documentation.
• Program complex Tables, Listings, and Figures (TLFs) for study reports, publications, and submissions.
• Review and interpret statistical analysis plans (SAPs) to ensure accurate implementation in code.
• Serve as lead programmer on multiple studies and/or projects, coordinating efforts across internal teams and CROs.
• Provide technical oversight and mentoring to junior programmers and contractors.
• Collaborate closely with Biostatistics, Data Management, and Clinical teams to deliver timely and accurate outputs.
• Ensure programming deliverables comply with industry standards (CDISC, FDA, EMA) and internal SOPs.
• Contribute to the development and implementation of programming standards and reusable code libraries.
• Participate in quality control, peer review, and validation of programming deliverables.
• Prepare and review submission ready datasets, define.xml files, and reviewer guides for regulatory authorities (e.g., FDA, EMA).
• Support integrated summaries of safety (ISS) and efficacy (ISE) analyses for NDA/BLA/MAA submissions.
• Use tools such as Pinnacle 21, OpenCDISC, and define.xml generators to ensure submission compliance.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelors Degree or Masters degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field.
• 7-9 years in statistical programming within the pharmaceutical, biotech, or CRO industry.
• Expert level proficiency in SAS Base, SAS Macro, and SAS SQL.
• In depth experience with CDISC SDTM and ADaM standards.
• Proven track record of supporting clinical trial reporting and regulatory submissions.
• Strong understanding of ICH GCP, 21 CFR Part 11, and FDA and EMA regulatory expectations.
• Excellent problem solving skills and attention to detail.
• Strong communication and collaboration skills.

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