Clinical SAS Programmer
About the position
Responsibilities
• Develop, test, and validate SAS programs for clinical trial data analysis and reporting.
• Generate and QC tables, listings, and figures (TLFs) for clinical study reports.
• Provide programming support for data management, data review, and ad hoc analyses.
• Ensure compliance with regulatory requirements (e.g., FDA, EMA) and company standards.
• Participate in the creation of submission documentation for regulatory filings.
• Collaborate with statisticians and other team members to ensure timely and accurate delivery of high-quality datasets and outputs.
• Perform programming and validation of data integration and data mapping as necessary.
Requirements
• Bachelor's degree in Computer Science, Statistics, Mathematics, or a related field; advanced degree preferred.
• At least 3 years of experience as a SAS programmer in the pharmaceutical or biotechnology industry.
• Strong experience with SAS programming (data step, PROC SQL, macros, and statistical procedures).
• Demonstrated experience with Pinnacle 21 and submissions to regulatory authorities.
• Knowledge of CDISC standards (SDTM, ADaM) and regulatory submission requirements.
• Excellent problem-solving skills and attention to detail.
• Strong communication and collaboration abilities.
Nice-to-haves
• Exposure to clinical trials in rare diseases.
• Experience with other programming languages (e.g., R, Python).
• Familiarity with clinical data management systems (e.g., Medidata Rave, Oracle Clinical).
Benefits
• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
• Access to a retirement savings plan.
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year).
• Transit spending account.
• Paid sick leave under the applicable state or local plan.
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