ClinChoice is searching for a
Associate Director, Biostatistics Consultant - Oncology to join one of our clients.
We are seeking an experienced and highly motivated
Associate Director of Biostatistics with strong expertise in oncology clinical development to provide statistical leadership across clinical trials and development programs. The successful candidate will lead statistical strategy, oversee the design and analysis of clinical studies, ensure the quality of statistical deliverables, and collaborate closely with cross-functional teams to support clinical development and regulatory submissions.
This role requires extensive knowledge of oncology clinical trials, strong leadership capabilities, and the ability to provide strategic statistical guidance to internal teams and external stakeholders.
Key Responsibilities- Provide statistical leadership and strategic guidance for oncology clinical development programs, including Phase I-III clinical trials.
- Lead the development and review of statistical analysis plans (SAPs), statistical methodologies, sample size calculations, and randomization strategies.
- Provide expertise in oncology endpoints, including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and disease control rate (DCR).
- Oversee the statistical analysis of clinical trial data, including time-to-event analyses, Kaplan-Meier estimation, Cox proportional hazards models, and other appropriate statistical methods.
- Review and provide oversight of clinical study reports (CSRs), tables, listings, figures (TLFs), and other statistical deliverables to ensure scientific accuracy and regulatory compliance.
- Support regulatory submissions and interactions with health authorities, including the FDA, EMA, and other global regulatory agencies.
- Provide statistical input into clinical study protocols, clinical development plans, and integrated analyses.
- Collaborate with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Writing, and Regulatory Affairs teams.
- Serve as a statistical subject matter expert in client meetings, project discussions, and strategic planning sessions.
- Mentor and provide technical guidance to biostatisticians and other statistical team members.
- Ensure adherence to applicable regulatory guidelines, industry standards, and internal quality procedures.
- Contribute to business development activities, including proposal development, feasibility assessments, and client presentations, as needed.
Qualifications- PhD in Statistics, Biostatistics, or a closely related quantitative discipline; a Master's degree with substantial relevant experience may also be considered.
- Extensive experience in biostatistics within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.
- Strong experience supporting oncology clinical trials, preferably across multiple phases of clinical development.
- Demonstrated expertise in survival analysis, time-to-event endpoints, clinical trial design, hypothesis testing, and statistical modeling.
- Thorough understanding of oncology efficacy endpoints, response assessment criteria such as RECIST, and relevant clinical development considerations.
- Experience preparing and reviewing SAPs, CSRs, regulatory submission documents, and integrated analyses.
- Knowledge of FDA, EMA, ICH, and other applicable regulatory guidelines.
- Strong leadership, communication, problem-solving, and stakeholder management skills.
- Ability to manage multiple projects, prioritize deliverables, and work effectively in a collaborative, fast-paced environment.
The Application ProcessOnce you have submitted your CV, you will receive an acknowledgement that we have received it. If you have the requirements we need, you will be invited for a 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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