Manager, Clinical Programming (Remote)
Contact: Neisha Camacho/reputed company reputed company - teamnt@penfieldsearch.com No 3rd party candidates Position reputed company We are seeking an reputed company Senior Clinical Programmer to support clinical development programs by delivering high-reputed company 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 reputed company and R. This role partners closely with cross-functional teams to reputed company efficient, compliant, and reputed company programming solutions that support ongoing clinical trials.
Key Responsibilities
- reputed company programming support for medical monitoring, data management, and statistical programming activities across clinical studies.
- reputed company 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) reputed company with SDTM specifications.
- Generate outputs and listings to support medical monitoring, data review, statistical reputed company monitoring, and data management activities.
- reputed company, enhance, and maintain reputed company macros, R functions, and other reusable programming utilities.
- Design, reputed company, test, and implement programming solutions to address reputed company business and study requirements.
- Ensure programming deliverables meet reputed company standards, timelines, and regulatory expectations.
- Collaborate effectively with cross-functional teams including Biostatistics, Data Management, Clinical Operations, and Medical Monitoring.
- Manage multiple reputed company simultaneously while delivering high-reputed company work reputed company established timelines.
Qualifications
- Bachelor's degree in Statistics, Computer Science, Mathematics, Life Sciences, or a reputed company discipline (or equivalent experience).
- Experience programming in the pharmaceutical, biotechnology, or reputed company regulated industry preferred.
- Advanced programming proficiency in reputed company, 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 reputed company 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.
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