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Associate Director, Biostatistics Consultant – Oncology - (Remote in UK- Outside IR35)

Clinchoice
Contract type
One-time
Work mode
Remote
Experience
Lead / principal · Not stated

Level inferred from job title

Job description

Associate Director, Biostatistics Consultant – Oncology role at ClinChoice, working directly for a single client sponsor. 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 Go/No-Go decision gates and proof-of-concept criteria for Phase II trials
  • Build futility stopping rules into trial protocols
  • 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
  • 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

  1. 1Receive an acknowledgement that the CV was received
  2. 2Phone interview as the first step

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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 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

  • Diversity and inclusivity
  • Continuous training and development of personnel