ClinChoice - Associate Director, Biostatistics Consultant – Oncology -

• Selecting Trial Types: decide if a trial should be superiority, non-inferiority, or equivalence-based depending on what regulators and payers need to prove the drug beats a placebo or standard of care. • Endpoint Selection: define and validate primary and secondary endpoints (e.g., overall survival, biomarker response rates, quality-of-life scores) to ensure they are measurable, clinically meaningful, and statistically robust. • Innovative Designs: statisticians frequently design adaptive trials (e.g., seamless Phase II/III designs, group sequential designs, or biomarker-driven basket/umbrella trials) to save time and patients. • adaptive trials • Sample Size & Power Calculations • Balancing Risk and Resources:  use power calculations to ensure a trial has a high probability of detecting a true clinical effect without enrolling excess patients, which drives up costs and exposes unnecessary individuals to experimental risks. • Subgroup Powering: They determine if the study is large enough to analyze specific patient subsets (e.g., biomarker-positive patients or specific age groups). • Establishing Go/No-Go Decision Gates • Go/No-Go Decision Gates • Proof-of-Concept Criteria: establish quantitative thresholds for Phase II trials (e.g., "If the hazard ratio is below 0.70 with a p-value , we proceed to Phase III"). • Futility Stopping Rules: Experience in build rules into trial protocols to stop a failing trial early, preventing sunk costs on a drug that is unlikely to succeed. • Regulatory Strategy and Health Authority Negotiations : experience in preparing and reviewing data packages and attending meetings with regulatory bodies (like the FDA or EMA) to defend trial designs, proposed endpoints, and statistical analysis plans (SAPs). • Mitigating Regulatory Risk: Experience in anticipating and addressing statistical objections from health authorities regarding missing data handling, multiplicity adjustments (controlling for false positives when looking at multiple endpoints), and bias. • At the macro–Strategic Drug Development level, statisticians should have experience working with commercial and portfolio management teams. • commercial and portfolio management teams • Quantifying Uncertainty: Experience in using historical benchmark data and simulation models to estimate the Probability of Technical Success (PoS) for an asset at each development phase. • Pipeline Prioritization: Using risk models to help executive leadership in deciding whether to advance, partner, or kill an asset based on its statistical likelihood of clearing regulatory and market hurdles. • Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative discipline. • Demonstrated experience in strategic drug development and clinical trial design, beyond traditional study-level responsibilities. • strategic drug development and clinical trial design • Strong knowledge of oncology endpoints, adaptive designs, sample size/power, simulations, and statistical methodology. • Experience supporting regulatory submissions and health authority interactions. • regulatory submissions and health authority interactions • Excellent communication and leadership skills with the ability to influence senior cross-functional stakeholders. • The Application Process • Once 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? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. • Our Company Ethos • Our Company Ethos • Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.