Associate Director, Biostatistics Consultant – Oncology

This is a fully remote position, open to applicants in Europe.

📋 Description

• Offer strategic statistical direction across various development initiatives

• Collaborate effectively with Clinical Development, Regulatory, Medical, Commercial, and Portfolio teams

• Choose among superiority, non-inferiority, or equivalence trial designs

• Define and validate primary and secondary endpoints in oncology

• Create adaptive, seamless Phase II/III trials, including group sequential, basket, and umbrella designs

• Conduct calculations for sample size, power, and subgroup analysis

• Set go/no-go decision criteria, proof-of-concept benchmarks, and futility stopping rules

• Prepare and evaluate data packages and participate in FDA or EMA health authority discussions

• Tackle regulatory issues related to missing data, multiplicity, and bias

• Utilize benchmark data and simulation techniques to assess Probability of Technical Success

• Assist in decisions regarding pipeline prioritization, including advancing, partnering, or halting assets

⛳️ Requirements

• Master's or Ph.D. in Statistics, Biostatistics, or a related quantitative field

• Extensive experience within pharmaceutical, biotechnology, or CRO settings, particularly in oncology

• Proven track record in strategic drug development and clinical trial design that extends beyond traditional study-level duties

• In-depth understanding of oncology endpoints, adaptive designs, sample size/power calculations, simulations, and statistical methods

• Experience in supporting regulatory submissions and engaging with health authorities

• Exceptional communication and leadership abilities, with a talent for influencing senior cross-functional stakeholders

🏝️ Benefits

• Ongoing training and opportunities for professional growth

• Supportive management and training environment

• Commitment to equal opportunity and a diverse workplace