Senior Statistical Programmer Consultant (Oncology) Remote
ClinChoice · Horsham, PA · 3 wk ago
RemoteRemoteAnalystFull-time
About the role
ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of their clients. The role offers a unique blend of direct sponsor interaction and global CRO benefits.
Responsibilities
- Lead programming activities for oncology clinical trials across multiple studies.
- Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
- Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
- Provide SAS programming expertise to support complex data derivations and analyses.
- Review and ensure traceability, consistency, and quality of all programming deliverables.
- Act as programming lead for assigned studies, managing timelines and deliverables.
- Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.
- Cover coordination with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.
- Support integrated analyses including ISS/ISE.
- Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.
- Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).
- Contribute to responses for regulatory queries and data requests.
Qualifications
- Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
- 8–12+ years of statistical programming experience in pharma/biotech or CRO.
- Expert-level proficiency in SAS.
- Strong understanding of CDISC SDTM and ADaM standards.
- Significant experience supporting oncology clinical trials (hematologic or solid tumors).
- Experience supporting regulatory submissions and preparing submission-ready outputs.
- Excellent communication skills and ability to collaborate cross-functionally.
Benefits
Working at ClinChoice offers a unique combination of direct sponsor interaction and global CRO benefits. As a global full-service CRO, ClinChoice specializes in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of proven high-quality delivery and results, ClinChoice has over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Pay
The pay range for this position is $75,000 - $100,000 per year.
Schedule
This role is full-time.