Manager, Statistical Programming Consultant - Oncology - Remote
ClinChoice
Summary
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.
Job description
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.
Requirements
- 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
Company overview
ClinChoice is a leading global full-service Contract Research Organization (CRO) with over three decades of proven expertise in pharmaceutical, biotechnology, medical device, and consumer health sectors. Founded in 1995 and headquartered in Horsham, Pennsylvania, the company has established itself as a trusted partner for product development and lifecycle management services worldwide. With a strong presence across the Americas, Europe, and Asia-Pacific regions, ClinChoice delivers exceptional clinical trial execution, regulatory expertise, pharmacovigilance, and biometrics capabilities. The company employs between 1,001-5,000 professionals and has demonstrated outstanding results in supporting clients through comprehensive clinical development programs. ClinChoice maintains ISO 9001:2015 and ISO 14155:2020 certifications, reflecting its commitment to quality and compliance standards in the life sciences industry.