Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds....
ClinChoice is searching for a
Principal Statistical Programmer Consultant to join one of our clients.
Position OverviewWe are seeking an experienced
Principal Statistical Programmer to provide programming expertise and leadership in support of clinical development programs, primarily focused on solid tumor oncology studies.
The ideal candidate will have extensive experience in clinical trial statistical programming, strong SAS programming skills, and in-depth knowledge of oncology endpoints, CDISC standards, and regulatory submission requirements. This individual will contribute to the development and execution of clinical programming deliverables across Phase I-III clinical trials.
Key Responsibilities- Lead and oversee statistical programming activities for oncology clinical trials, with a primary focus on solid tumor indications.
- Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards.
- Program and review complex TFLs (Tables, Figures, and Listings) for clinical study reports and regulatory submissions.
- Support oncology efficacy and safety analyses, including Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR), Duration of Response (DoR), and Disease Control Rate (DCR).
- Demonstrate expertise in Kaplan-Meier analysis, Cox proportional hazards models, and other time-to-event analyses.
- Work closely with biostatisticians, data management, clinical teams, and cross-functional stakeholders to ensure timely and high-quality deliverables.
- Provide technical leadership, programming oversight, and mentorship to junior and senior statistical programmers.
- Review programming specifications, analysis datasets, and statistical outputs for accuracy and consistency.
- Support regulatory submissions and respond to health authority requests, as needed.
- Identify opportunities to improve programming standards, processes, and efficiencies.
Required Qualifications- Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline.
- Extensive experience in clinical statistical programming within the pharmaceutical or biotechnology industry.
- Strong hands-on experience with SAS programming, including SAS Base, SAS Macro, and SAS/STAT.
- Significant experience supporting solid tumor oncology clinical trials, preferably across Phase I, II, and III studies.
- Strong knowledge of oncology efficacy endpoints, including OS, PFS, ORR, and DoR.
- Expertise in CDISC SDTM and ADaM standards.
- Experience developing and validating complex TFLs for clinical study reports and regulatory submissions.
- Knowledge of ICH-GCP and regulatory requirements (FDA/EMA).
- Excellent communication, problem-solving, and cross-functional collaboration skills.
Preferred Qualifications- Experience with immuno-oncology and targeted cancer therapies.
- Exposure to clinical trials involving head and neck, lung, colorectal, breast, or other solid tumor indications.
- Experience with FDA or EMA regulatory submissions.
- Prior experience providing technical leadership and mentoring statistical programming teams.
The Application ProcessOnce you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
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