Job Description
- 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/Skilled 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 communicat