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Senior/Principal Statistician Consultant – Phase III Oncology
ClinChoice. Provide statistical expertise and hands-on support for Phase III oncology clinical trials .
About the role
Key responsibilities & impact- Provide statistical expertise and hands-on support for Phase III oncology clinical trials
- Contribute to study design, statistical analysis, interpretation of results, and clinical study deliverables
- Apply censoring and time-to-event analyses
- Apply and interpret Kaplan-Meier analysis, Cox Proportional Hazards models, and stratified log-rank tests
- Author, review, and provide input into TFL and ADaM specifications with Statistical Programming
- Review statistical programming outputs, identify discrepancies, and collaborate with programmers to resolve issues
- Use SAS to review outputs and perform data and analysis checks
- Manage deliverables across multiple concurrent clinical studies
- Collaborate with Biostatistics, Statistical Programming, Data Management, Clinical, Regulatory, and other cross-functional teams
- Support interim analyses and IDMC/DMC activities, including preparation and review of DMC outputs
Requirements
What you’ll need- Advanced degree (MS, PhD, or equivalent) in Statistics, Biostatistics, or a related quantitative field
- Direct hands-on experience supporting at least one Phase III oncology clinical trial
- Strong understanding of oncology clinical trial endpoints, including OS, PFS, ORR, and DoR
- Strong knowledge of censoring rules and time-to-event analysis
- Hands-on experience with Kaplan-Meier, Cox Proportional Hazards, and stratified log-rank methods
- Strong SAS programming skills
- Experience authoring or reviewing TFL and ADaM specifications
- Ability to identify and resolve discrepancies in analysis outputs
- Ability to work independently with minimal supervision
- Ability to manage deliverables across multiple concurrent clinical trials
- Excellent written and verbal communication skills
- Experience supporting FDA and/or EMA regulatory submissions preferred
- Experience with IDMC/DMC activities and interim analyses preferred
- Experience with R programming is a plus
- Experience working in a CRO, pharmaceutical, or biotechnology environment preferred
Benefits
Comp & perks- Professional growth opportunities
- Continuous training and development
- Equal opportunity and diversity-focused workplace