We are seeking an experienced
Senior/Principal Biostatistician with strong hands-on experience supporting
Phase III oncology clinical trials. The ideal candidate will have a solid understanding of oncology study design and statistical methodology, strong SAS skills, and the ability to work independently across multiple concurrent studies.
This role will collaborate closely with Statistical Programming and cross-functional teams to support study deliverables, including TFLs, ADaM specifications, interim analyses, and regulatory submissions.
Key Responsibilities- 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.
- Demonstrate a strong understanding of key oncology endpoints, including:
- Overall Survival (OS)
- Progression-Free Survival (PFS)
- Objective Response Rate (ORR)
- Duration of Response (DoR)
- Apply appropriate methods for censoring and time-to-event analyses.
- Apply and interpret statistical methodologies including:
- Kaplan-Meier analysis
- Cox Proportional Hazards models
- Stratified log-rank tests
- Author, review, and provide input into TFL and ADaM specifications in close collaboration with Statistical Programming.
- Review statistical programming outputs, identify discrepancies, and work collaboratively with programmers to resolve issues.
- Use SAS to independently review outputs and perform data and analysis checks.
- Manage deliverables across multiple concurrent clinical studies, ensuring timelines and quality expectations are met.
- Work independently with minimal supervision and quickly become familiar with study requirements, datasets, and programming outputs.
- Collaborate with Biostatistics, Statistical Programming, Data Management, Clinical, Regulatory, and other cross-functional teams as required.
- Support interim analyses and Independent Data Monitoring Committee (IDMC/DMC) activities, including preparation and review of DMC outputs.
Required Qualifications- 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 with the ability to review statistical programming outputs and perform independent checks.
- Experience authoring or reviewing TFL and ADaM specifications and collaborating closely with Statistical Programming.
- Strong problem-solving skills with the ability to identify and resolve discrepancies in analysis outputs.
- Ability to work independently, quickly onboard to new studies, and operate effectively with minimal supervision.
- Demonstrated ability to manage deliverables across multiple concurrent clinical trials while maintaining quality and timelines.
- Excellent written and verbal communication skills.
Preferred Qualifications- Experience supporting FDA and/or EMA regulatory submissions.
- Experience with IDMC/DMC activities and interim analyses, including preparation and review of DMC outputs.
- Experience with R programming is a plus.
- Experience working in a CRO, pharmaceutical, or biotechnology environment.
Key Competencies- Phase III Oncology
- Time-to-Event Analysis
- Survival Analysis
- SAS
- TFL and ADaM Specifications
- Statistical Programming Collaboration
- Clinical Trial Analysis
- Regulatory Submissions
- IDMC/DMC Support
- Multi-Study Project Management
- Independent/Self-Directed Work
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.
Who will you be working for?#LI-TT1 #LI-Remote #LI-Principal #contract
