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
Manager, Statistical Programmer Consultant to join one of our clients.
We are seeking an experienced Manager, Statistical Programming Consultant with strong expertise in oncology clinical trials, particularly solid tumor studies, to lead and oversee statistical programming activities across clinical development programs.
The ideal candidate will have strong technical expertise in SAS programming, CDISC standards, and regulatory submissions, along with proven experience managing programming teams and delivering high-quality clinical trial outputs.
Key Responsibilities- Lead and oversee statistical programming activities across Phase I, II, and III oncology clinical trials.
- Manage, mentor, and provide technical guidance to statistical programmers.
- Oversee the development, validation, and delivery of SDTM and ADaM datasets and Tables, Listings, and Figures (TFLs).
- Ensure accurate implementation of Statistical Analysis Plans (SAPs) and oncology-specific endpoints, including OS, PFS, ORR, and DoR.
- Provide programming oversight for survival analysis, Kaplan-Meier curves, and RECIST 1.1-based tumor response assessments.
- Collaborate closely with Biostatistics, Data Management, and other cross-functional teams.
- Manage project timelines, resource allocation, and programming deliverables.
- Ensure compliance with CDISC standards, FDA/EMA requirements, and applicable regulatory guidelines.
Required Qualifications- Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, or a related discipline.
- 8+ years of experience in statistical programming within the pharmaceutical, biotechnology, or CRO industry.
- Prior experience in a managerial, team lead, or programming lead role.
- Strong hands-on expertise in SAS programming.
- Extensive experience supporting oncology clinical trials, particularly solid tumor studies.
- Strong knowledge of CDISC standards, SDTM, ADaM, and TFL development.
- Experience with oncology endpoints, survival analysis, and RECIST 1.1.
- Proven ability to lead programming teams and manage multiple clinical study deliverables.
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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