Senior Statistical Programmer/Analyst Consultant (Need solid oncology background) Remote in US
Core
Lead statistical programming activities for clinical studies in the oncology therapeutic area, from study start-up through database lock, analysis, and reporting.
Role type
Senior Statistical Programmer Consultant (Oncology)
Builds
CDISC-compliant SDTM and ADaM datasets, Tables, Listings, and Figures (TLFs), and regulatory submission packages
Domain
Clinical Trials / Oncology / Biostatistics
Required skills
SAS programming (Base SAS, procedures), CDISC standards (SDTM, ADaM), TLF development, clinical trial data management, regulatory submission support, study-level programming leadership
Preferred skills
R programming, oncology clinical trial experience, mentorship of junior programmers
Technologies
SAS, R, CDISC SDTM, CDISC ADaM
Responsibilities
Lead statistical programming activities for clinical studies within the oncology therapeutic area; Develop, review, and maintain high-quality SAS programs for SDTM, ADaM, and TLFs; Lead programming activities for interim and final analyses; Work closely with Biostatisticians to understand statistical analysis plans; Develop and review programming specifications; Support the creation and validation of CDISC-compliant datasets; Generate and validate TLFs for clinical study reports; Perform independent programming validation and quality control; Support submission-related activities; Identify potential programming issues and communicate risks; Coordinate programming activities across studies; Provide technical guidance and mentorship to team members; Participate in client/project meetings and communicate technical information.
Seniority
Senior, hands-on IC with leadership responsibilities
