Principal Statistical Programmer Consultant – Oncology, Solid Tumors

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and manage statistical programming efforts for oncology clinical trials, primarily emphasizing solid tumor indications.

• Develop, validate, and sustain SDTM and ADaM datasets, ensuring compliance with CDISC standards.

• Program and review intricate tables, figures, and listings for clinical study reports and regulatory submissions.

• Assist in oncology efficacy and safety analyses, including Overall Survival, Progression-Free Survival, Objective Response Rate, Duration of Response, and Disease Control Rate.

• Conduct Kaplan-Meier analysis, Cox proportional hazards models, and other time-to-event analyses.

• Collaborate with biostatisticians, data management teams, clinical teams, and cross-functional stakeholders.

• Provide technical guidance, programming oversight, and mentorship to statistical programming staff.

• Review programming specifications, analysis datasets, and statistical outputs for precision and consistency.

• Support regulatory submissions and address inquiries from health authorities.

• Enhance programming standards, processes, and operational efficiencies.

⛳️ Requirements

• Bachelor’s or Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field.

• Extensive experience in clinical statistical programming in the pharmaceutical or biotechnology sector.

• Strong practical experience with SAS programming, including SAS Base, SAS Macro, and SAS/STAT.

• Significant background supporting solid tumor oncology clinical trials, preferably across Phase I, II, and III studies.

• In-depth knowledge of oncology efficacy endpoints, including OS, PFS, ORR, and DoR.

• Proficiency in CDISC SDTM and ADaM standards.

• Experience in developing and validating complex TFLs for clinical study reports and regulatory submissions.

• Familiarity with ICH-GCP and regulatory requirements (FDA/EMA).

• Exceptional communication, problem-solving, and cross-functional collaboration skills.

• Experience with immuno-oncology and targeted cancer therapies.

• Exposure to clinical trials related to head and neck, lung, colorectal, breast, or other solid tumor indications.

• Experience with FDA or EMA regulatory submissions.

• Previous experience in providing technical leadership and mentoring statistical programming teams.

🏝️ Benefits

• Professional development opportunities.

• Supportive work culture.

• Ongoing training programs.

• Close management and training support.

• Career advancement opportunities by working with a global CRO.

• Client-facing role in a high-trust environment.