Senior Clinical Statistical Programmer – III

Job Description

Job summary:

• 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.

Duties and Responsibilities:

• Provide expert-level hands-on support for all internal statistical programming needs for clinical, device studies including but not limited to CSR, ISS and Client 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.

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.