Senior Statistical Programmer Consultant, Oncology

Jobtailor; Deutschland; Vor Ort; EUR 90.000 - 150.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced Senior SAS Programmer Lead to drive programming activities for oncology clinical trials. You will develop, validate, and maintain SDTM and ADaM datasets per CDISC guidelines and oversee Tables, Listings, and Figures for study reports and submissions.

The role requires expert SAS skills, strong experience in oncology trials, and a track record supporting regulatory submissions with clear cross-functional collaboration across Biostatistics, Data Management,

Qualifikationen

• 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.

Aufgaben

• 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.
• Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.
• Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.

Kenntnisse

SAS programming

CDISC SDTM/ADaM

Oncology trials experience

Regulatory submissions

Cross-functional collaboration

Leadership in programming

Communication skills

Ausbildung

Bachelor’s or Master’s degree in Statistics/CS/Math/Life Sciences

Jobbeschreibung

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.
• Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.
• Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.

Requirements

• 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.