Contact: Neisha Camacho/Terra Parsons - [email protected]
No 3rd party candidates
Position Summary
We are seeking an experienced Senior Clinical Programmer to support clinical development programs by delivering high-quality programming solutions for medical monitoring, data management, and statistical programming activities. The ideal candidate has strong expertise in CDISC standards, SDTM dataset development, and modern programming tools including SAS and R. This role partners closely with cross-functional teams to develop efficient, compliant, and scalable programming solutions that support ongoing clinical trials.
Key Responsibilities
- Provide programming support for medical monitoring, data management, and statistical programming activities across clinical studies.
- Develop specifications for SDTM dataset creation in accordance with CDISC SDTM Implementation Guide (SDTM IG).
- Program, validate, and maintain CDISC-compliant SDTM datasets.
- Create and maintain annotated CRFs (aCRFs) aligned with SDTM specifications.
- Generate outputs and listings to support medical monitoring, data review, statistical endpoint monitoring, and data management activities.
- Develop, enhance, and maintain SAS macros, R functions, and other reusable programming utilities.
- Design, develop, test, and implement programming solutions to address complex business and study requirements.
- Ensure programming deliverables meet quality standards, timelines, and regulatory expectations.
- Collaborate effectively with cross-functional teams including Biostatistics, Data Management, Clinical Operations, and Medical Monitoring.
- Manage multiple projects simultaneously while delivering high-quality work within established timelines.
Qualifications
- Bachelor's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a related discipline (or equivalent experience).
- Experience programming in the pharmaceutical, biotechnology, or related regulated industry preferred.
- Advanced programming proficiency in SAS, R, and SQL.
- Strong working knowledge of CDISC standards, including SDTM and annotated CRFs.
- Experience with JReview is highly preferred.
- Experience with Shiny, Pharmaverse, and R Markdown is preferred.
- Familiarity with programming languages such as Python, VBA, or C++ is a plus.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work independently while collaborating effectively within cross-functional teams.
- Strong organizational skills with the ability to prioritize multiple assignments and meet deadlines.
Preferred Experience
- Experience supporting medical review or clinical data review activities.
- Experience developing reusable programming utilities and automation tools.
- Familiarity with regulatory submission standards and clinical trial data workflows.
- Experience working in a fast-paced clinical development environment.
