Responsibilities of the Principal Statistical Programmer:
* Manage and collaborate with external vendors and CROs to ensure high-quality deliverables.
* Serve as the lead statistical programmer on clinical studies, overseeing programming activities both internally and externally.
* Develop, validate, and maintain SAS programs for data manipulation, analysis, and reporting.
* Create and validate CDISC-compliant datasets and define.xml files for regulatory submissions.
* Generate and/or validate tables, listings, and figures (TLFs) for clinical study reports (CSRs) and publications.
* Collaborate closely with biostatistics, data management, clinical, and safety teams to ensure data quality and integrity.
* Provide programming support for regulatory interactions and submissions.
* Contribute to the development and implementation of standardized programming processes, macros, and automation tools to enhance efficiency.
* Ensure compliance with Good Programming Practices (GPP), ICH guidelines, and company SOPs.
Requirements of the Principal Statistical Programmer:
* MS or PhD degree or above in Biostatistics, Statistics, Mathematics, Computer Science, or a related field.
* 5+ years of relevant statistical programming experience using SAS; knowledge of R is a plus.
* Must have 2+ years of oncology experience in a clinical trial setting.
* Strong knowledge of CDISC standards and experience working with electronic data capture (EDC) systems such as Medidata Rave.
* Solid understanding of the drug development process and clinical trials.
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Science, Research, and Strategy/Planning
* Industries
Staffing and Recruiting
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