Senior Clinical & Statistical Programmer
New
J
JobgetherClinical trials
The position is open to remote candidates across the United StatesFull-TimeSenior
Salary153,000 - 189,000 USD per year
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Job Details
- Experience
- At least 5 years of relevant clinical and statistical programming experience
- Required Skills
- R
Requirements
- Bachelor's degree in Biostatistics, Statistics, Computer Science, or a closely related discipline.
- At least 5 years of relevant clinical and statistical programming experience in the pharmaceutical, biotechnology, or CRO industry.
- Hands-on experience developing and validating clinical trial programming deliverables, supporting study execution, and preparing regulatory submissions.
- Advanced SAS programming skills and a strong understanding of statistical programming principles.
- Thorough knowledge of CDISC standards, including SDTM and ADaM.
- Strong working knowledge of ICH, FDA, and Good Clinical Practice (GCP) regulations and guidelines.
- Ability to work with detailed technical documentation, datasets, tables, listings, figures, and other on-screen materials for extended periods.
- Ability to travel up to 10% as needed.
- A master's degree is preferred.
- Preferred experience supporting NDA or BLA submissions, interacting with regulatory agencies, and leading early- and late-phase clinical trials.
- Preferred experience in immunology, hematology, or oncology clinical trials.
- Preferred experience using R for clinical analysis.
Responsibilities
- Perform clinical and statistical programming across the clinical trial lifecycle.
- Develop, validate, and quality-check SDTM and ADaM datasets, specifications, tables, listings, and figures in accordance with CDISC standards.
- Provide SAS programming support for safety, efficacy, exploratory, ad hoc, and publication analyses.
- Review protocols, statistical analysis plans, case report forms, and data specifications for programming requirements.
- Validate programming outputs, identify issues, and implement resolutions.
- Review CRO, contractor, and external collaborator deliverables for quality, accuracy, consistency, and compliance.
- Support regulatory submissions with datasets, tables, listings, figures, define.xml files, reviewer guides, and supporting documentation.
- Develop and maintain reusable programs, macros, standards, SOPs, and tools.
- Collaborate with Biostatistics, Clinical Data Management, Clinical Operations, Medical, Safety, and Regulatory Affairs.
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