Clinical Statistical Programmer III Senior

Job description

Clinical Statistical Programmer - III (Senior)

3 months

Remote

Qualifications: Department: Clinical Data Sciences Reports to: Senior Director, Statistical Programming Title: Senior Statistical programming Contractor Background Requirements and Qualifications: * Minimum of 10+ years of hands-on statistical programming experience in the pharmaceutical, biotech, or CRO industry. * Advanced knowledge of GCP/ICH guidelines and FDA regulatory requirements; prior experience with NDA/MAA/BLA submissions is preferred. * Strong expertise in SAS programming and macro development; experience with R or Python is a plus. * In-depth knowledge of CDISC standards including SDTM, ADaM, Define.xml, and submission-ready datasets. * Demonstrated ability to manage multiple projects and shifting priorities in a fast-paced environment. * Excellent written and verbal communication skills. Skills: * Expert level proficiency in SAS programming and experience in CDISC SDTM/ADaM and submission standards * Expert level ability to write efficient, reusable macros and provide innovative programming solutions. * Strong project management skills with the ability to prioritize tasks and meet tight deadlines while maintaining high quality. * Familiarity with programming in R or Python for statistical analysis or automation is highly desirable. * Experience supporting regulatory submissions and publication requests. Responsibilities: Position Overview: Basic Functions & Responsibilities Responsible for providing expert-level, hands-on support across all internal statistical programming needs for clinical and device studies, regulatory submissions, and exploratory analyses, while also contributing to innovation and quality across the department. Other Primary Activities: * Provide expert-level hands-on support for all internal statistical programming needs for clinical, device studies including but not limited to CSR, ISS and ISE summaries and exploratory data analyses * Perform rigorous quality control (QC) of programming deliverables to ensure accuracy and compliance with regulatory standards. * Collaborate closely with biostatistics, data management, and cross-functional teams to support ongoing clinical trials, FDA submissions, publications, and other business needs. * Develop, validate, and maintain departmental standard macros and template programs. * Write and validate SAS programs to generate SDTM, ADaM datasets, and TLFs (Tables, Listings, and Figures). * Write, review, and approve data specifications for SDTM and ADaM datasets. * Contribute to the development and implementation of innovative programming strategies and tools. * Ensure adherence to departmental SOPs, guidelines, and regulatory requirements.

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