Sr. Statistical Programmer/ Principal Statistical Programmer (Home-based)

We are seeking a highly skilled and detail-oriented SAS Programmer to support our clinical development programs, with a strong emphasis on oncology, immunotherapy, and regenerative medicine. The ideal candidate will have experience in regulatory submissions including NDAs, as well as demonstrated hands-on expertise in statistical programming, data management, and quality control. This position requires close collaboration with cross-functional teams to ensure the integrity and accuracy of clinical data used in regulatory filings and internal reporting. Responsibilities and Duties: · Develop and validate complex SAS programs for the preparation of clinical study reports (CSRs), integrated summaries, regulatory submissions (including NDA), Investigator’s Brochures (IB), Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), and interim analyses. · Create, manage, and maintain analysis-ready datasets (e.g., ADaM) and submission datasets (e.g., SDTM) in accordance with CDISC standards. · Independently develop, validate, and troubleshoot SAS code, datasets, and statistical outputs to ensure high-quality, submission-ready deliverables that comply with internal standards and regulatory requirements. · Maintain and archive all programming files, datasets, outputs, and relevant documentation in accordance with regulatory and internal requirements. · Attend and contribute to technical meetings involving internal stakeholders and external partners, providing programming insights and solutions. · Ensure programming deliverables comply with CDISC standards (SDTM, ADaM) and regulatory guidance. · Support submission activities including preparation of data packages, eCTD deliverables, and responses to regulatory agencies. · Assist in mentoring junior programmers and reviewing their work as needed. Pay: $160,000.00 - $190,000.00 per year Work Location: Remote Apply tot his job Apply To this Job