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Associate Director, Biostatistics Consultant – Oncology - (Remote in UK- Outside IR35)
Contract type
One-time
Work mode
Remote
Experience
Lead / principal · Not stated
Level inferred from job title
Job description
An Associate Director, Biostatistics Consultant – Oncology role at ClinChoice, working directly for one client. The role provides strategic statistical leadership across oncology drug development programs and clinical trial strategy.
At a glance
- Employment
- Contract
- Work mode
- Remote
What you'll do
- Provide strategic statistical leadership across development programs
- Work closely with Clinical Development, Regulatory, Medical, Commercial, and Portfolio teams
- Select trial types (superiority, non-inferiority, or equivalence-based) depending on what regulators and payers need
- Define and validate primary and secondary endpoints (e.g., overall survival, biomarker response rates, quality-of-life scores)
- Design adaptive trials (e.g., seamless Phase II/III designs, group sequential designs, or biomarker-driven basket/umbrella trials)
- Perform sample size and power calculations
- Determine if the study is large enough to analyze specific patient subsets (e.g., biomarker-positive patients or specific age groups)
- Establish quantitative thresholds for Phase II trials as go/no-go decision gates
- Build futility stopping rules into trial protocols to stop a failing trial early
- Prepare and review data packages and attend meetings with regulatory bodies (like the FDA or EMA) to defend trial designs, proposed endpoints, and statistical analysis plans (SAPs)
- Anticipate and address statistical objections from health authorities regarding missing data handling, multiplicity adjustments, and bias
- Work with commercial and portfolio management teams on strategic drug development
- Use historical benchmark data and simulation models to estimate the Probability of Technical Success (PoS) for an asset at each development phase
- Use risk models to help executive leadership decide whether to advance, partner, or kill an asset
What we're looking for
- Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative discipline
- Significant experience in pharmaceutical, biotechnology, or CRO environments with strong oncology experience
- Demonstrated experience in strategic drug development and clinical trial design, beyond traditional study-level responsibilities
- Strong knowledge of oncology endpoints, adaptive designs, sample size/power, simulations, and statistical methodology
- Experience supporting regulatory submissions and health authority interactions
- Excellent communication and leadership skills with the ability to influence senior cross-functional stakeholders
How to get hired
- 1Receive an acknowledgement that the CV was received
- 2Phone interview as the first step if requirements are met
Apply
Direct apply at ClinChoice
Opens the job posting at ClinChoice
About ClinChoice
A global full-service CRO specializing in clinical development and functional solutions
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
Mission
To contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
Key facts
- over 4,000 professionals
- Contract Research Organization (CRO)
- Over 28 years of proven high-quality delivery and results across all our services
- Over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific
- Below industry average turnover rates
What they value
- Employees are the most valuable company asset
- Continuous training keeps resources qualified in terms of competence and expertise
- Diversity and inclusivity