Job SummaryThe Senior Statistical Programmer develops, validates, and documents statistical analysis programs to support clinical trial data analysis and regulatory submissions. This role leads programming activities, ensures deliverables meet industry and regulatory standards, and mentors junior programmers. The Senior Statistical Programmer collaborates closely with cross-functional teams, troubleshoots data and programming issues, and advances process improvements to optimize project outcomes.
Job Details/Responsibilities- Perform and support statistical programming activities, including the development, validation, documentation, and troubleshooting of statistical programs for clinical trial datasets (SDTM/ADaM) and outputs (tables, listings, and figures) supporting regulatory submissions and publications, ensuring timely delivery of high quality and reliable deliverables.
- Conduct comprehensive quality control checks and peer code reviews of programming deliverables to ensure accuracy, consistency, reliability, and compliance with regulatory requirements and programming standards.
- Collaborate with biostatisticians, data managers, and clinical operations, medical affairs, and other cross-functional teams to ensure project requirements are met and deliverables are aligned with project timeline and quality expectations.
- Act as the lead statistical programmer for assigned device types or therapeutic areas, providing technical leadership by directing programming activities, coordinating multiple concurrent projects, monitoring project progress and deliverables, and mentoring junior programmers to promote programming excellence and adherence to industry standards and best practices.
- Review project documentation, including Statistical Analysis Plans (SAPs), mock TLF shells, programming specifications, CRFs, and database design specifications, providing proactive and strategic feedback to optimize programming efficiency, enhance data quality, and reduce rework and implementation risks.
- Drive innovation within the department by leading process improvement and operational efficiency initiatives, promoting best practices, standardization, and continuous improvement across statistical programming activities.
Knowledge, Skills and Abilities (KSA)- Excellent written and verbal communication skills.
- Understanding of Statistical Analysis Plan (SAP) programming specifications.
- Knowledge of CDISC standards and requirements required.
- Strong attention to detail, accuracy, and initiative, with the ability to effectively manage multiple complex tasks simultaneously.
Qualifications/ Background Experiences- Bachelor's degree, preferably in a scientific, statistical, or related discipline, with a minimum of 5 years SAS programming experience in pharmaceutical, biotechnology, CRO, or medical device industry, or an equivalent combination of education, training and relevant experience.
- Extensive programming experience in SAS or other relevant software required, preferably within a clinical trial or regulated environment.
Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. The salary range is $86,900 - $121,880 based on experience plus a 10% target bonus.
