Note: The job is a remote job and is open to candidates in USA. SPECTRAFORCE is seeking a senior clinical statistical programming contractor to provide expert hands-on support for clinical and device studies, regulatory submissions, and exploratory analyses. The role develops and validates SAS programs, manages CDISC-compliant datasets and reporting outputs, performs quality control, and collaborates with cross-functional clinical teams.
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
- 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
Skills
- • 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
- • 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
- • Experience supporting regulatory submissions and publication requests
- • prior experience with NDA/MAA/BLA submissions is preferred
- • Familiarity with programming in R or Python for statistical analysis or automation is highly desirable
Company Overview
Company H1B Sponsorship