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Contact: Neisha Camacho/Terra Parsons -teamnt@penfieldsearch.com
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Overview:

Senior member of the Quantitative Sciences (QS) team, providing strategic leadership in the statistical design, analysis, and interpretation of oncology clinical trials. This role emphasizes advanced statistical methodology, innovative trial design, and integration of external data sources—including external control arms (ECAs) and hybrid controls—into Phase I–III oncology studies.

The position requires deep clinical trial expertise, regulatory experience, and the ability to apply rigorous statistical principles to generate high-quality, decision-enabling evidence. The Clinical Biostatistician will work closely with Clinical Development, Regulatory Affairs, Data Science, and other cross-functional partners to ensure studies are scientifically sound, compliant with regulatory expectations, and aligned with program objectives.

Key Responsibilities

• Lead statistical strategy for oncology trials incorporating ECAs, hybrid controls, and real-world data (RWD) to strengthen clinical evidence packages.
• Develop and apply innovative statistical methodologies—including bias mitigation (selection, confounding, measurement error), advanced survival models, and causal inference techniques.
• Act as regulatory-facing statistical lead—author statistical sections for protocols and SAPs, prepare briefing packages, respond to health authority queries, and represent the company in statistical discussions with FDA, EMA, and other agencies.
• Design and oversee statistical components of clinical trials, including:
• Feasibility assessments and endpoint selection
• Sample size and power calculations
• Randomization and stratification strategies
• Sensitivity and subgroup analyses
• Provide statistical leadership in adaptive and innovative trial designs, ensuring scientific validity and operational feasibility.
• Mentor internal teams on advanced statistical approaches, ECAs, and external data integration best practices.
• Collaborate on data collection and harmonization strategies to optimize statistical analyses.
• Contribute to scientific publications, conference presentations, and cross-industry collaborations in oncology biostatistics.

Requirements

• PhD or Master’s degree in Biostatistics, Statistics, or a related field.
• 6+ years of clinical trial biostatistics experience in oncology drug development, spanning multiple phases (II–III preferred).
• Demonstrated expertise in ECAs, hybrid controls, and RWD integration, including propensity score methods, Bayesian/frequentist borrowing, and advanced bias correction techniques.
• Strong knowledge of oncology clinical endpoints (e.g., OS, PFS, ORR) and statistical considerations in their analysis.
• Proven regulatory experience, including interaction with global health authorities and familiarity with current ECA/RWD guidance.
• Proficiency in SAS and R (Python a plus) with strong reproducible research practices.
• Experience with adaptive designs, survival modeling, and innovative statistical methodologies.
• Track record of effective cross-functional collaboration and the ability to translate statistical concepts to non-statistical stakeholders.
• Strong leadership, mentoring, and communication skills; able to influence strategy and decision-making.
• Ability to thrive in fast-paced, innovative environments balancing methodological rigor with operational realities.