Associate Director, Biostatistics Consultant – Oncology (Remote)

United States full time

Apply on Employer Site

Remote

senior

H1B: yes

Clinchoice Associate Director, Biostatistics Consultant – Oncology providing statistical leadership across oncology clinical trials and development programs. Lead design and analysis of clinical studies and collaborate with cross-functional teams for regulatory submissions.

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.

Qualification

PhD in StatisticsExperience preparing and reviewing SAPsKnowledge of FDAStrong leadershipAbility to manage multiple projectsThe Application ProcessOnce you have submitted your CVWho will you be working for?

Required

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 Process
Once 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.
Who will you be working for?