Planet Pharma · 8 hours ago
Senior Statistical Programmer (Clinical Trials)
Planet Pharma is seeking an experienced Senior Statistical Programmer to support early-stage clinical programs during a critical period of growth and patient dosing. This role involves designing and maintaining SAS programs for clinical trial data analysis, ensuring data integrity, and collaborating with cross-functional teams to enhance programming standards and documentation.
Responsibilities
Design, develop, and maintain SAS programs to analyze clinical trial data
Apply CDISC standards (SDTM, ADaM, Define.xml) to generate compliant datasets and outputs
Perform quality control and validation of statistical deliverables (tables, listings, figures)
Identify and resolve data inconsistencies to ensure data integrity and regulatory readiness
Support early-phase clinical trials with analysis and reporting, including patient-reported outcomes
Collaborate cross-functionally with biostatistics, data management, and clinical operations
Contribute to the development of internal programming standards, documentation, and best practices
Maintain organized project documentation, output shells, programming specifications, and QC records
Qualification
Required
5+ years of experience in statistical programming within the pharmaceutical or biotech industry
Strong SAS programming skills
Expert knowledge of CDISC standards (SDTM, ADaM, Define.xml)
Experience supporting Phase I–III clinical trials
Familiarity with regulatory guidelines (GCP, ICH, FDA/EMA expectations)
Ability to work independently, manage priorities, and thrive in fast-paced environments
Strong attention to detail, problem-solving ability, and communication skills
Master's degree in statistics, computer science, mathematics, or a related field preferred
Authorized to work in the U.S. (no sponsorship available)
Preferred
Experience in early-stage or growing biotech environments
Experience with patient-reported outcomes, eCOA platforms, or complex clinical data
Therapeutic experience in neurology or other complex disease areas
Experience contributing to or building internal standards, SOPs, or infrastructure