Senior Statistical Programmer

Statistical Programmer

Contribute to or lead statistical programming activities for Phase I to IV clinical trials. Develop and validate datasets, tables, listings, and figures (TFLs) according to specifications. Build and maintain effective working relationships with cross-functional teams (e.g., biostatistics, data management, clinical teams). Participate in team meetings and communicate programming progress and issues. Adhere to company, departmental, and industry standards (e.g., CDISC SDTM/ADaM, GCP). Ensure audit readiness and compliance with regulatory requirements. Review or develop programming specifications as part of statistical analysis plans. Participate in or lead the review of eCRFs and data structures. Ensure accuracy, reliability, and quality of statistical analysis results. Perform quality control checks on deliverables. Use SAS and other statistical programming tools (R and/or Python) effectively. Attend functional meetings and training sessions to enhance skills and knowledge. (At senior levels) Mentor and guide junior programmers. Contribute to process improvement, standardization, and non-clinical initiatives. Unique Key Activities: Lead programming for studies or project-level activities. Coordinate other programmers from the study or project. Represent programming in Clinical Trial Teams (CTTs), if performing the TP role. Provide input into programming solutions and project-level standards. Ensure quality and timely deliverables for all study level milestones like DMCs, IAs, Publications, CSRs, submissions etc. Mentor junior programmers and contribute to process improvements.

Experience/Professional Requirements: Ideally 6-10 years of experience. Proven ability to deliver quality outputs and coordinate teams. Strong knowledge of CDISC and regulatory frameworks. Good understanding of regulatory requirements (e.g., GCP, ICH, etc.). Proficiency in R programming may be considered. Excellent communication and collaboration skills