Principal Biostatistician, FSP

Job Description:

• Lead one Phase I-IV clinical study across the region
• Provide statistical and development support and influence for associated client trials
• Provide expertise in processes, clinical development plans, concept sheets, and protocols
• Potentially provide oversight of work supported by other vendors
• Formulate integrated analytical approaches to mine data sources
• Employ statistical methods, machine learning, and deep learning algorithms to discover actionable insights and automate processes
• Participate in development of study protocols, including study design discussions and sample size calculations
• Participate in exploratory data analyses to evaluate emerging study trends, support scientific decision-making, and generate insights throughout development
• Apply advanced statistical methodologies, including mixed models and other complex modeling techniques, to support efficacy and longitudinal analyses
• Design and execute simulation studies to evaluate study designs, operating characteristics, and statistical methodologies
• Lead and contribute to efficacy analyses and interpretation of primary and secondary endpoints
• Review CRFs and data review guidelines; develop Statistical Analysis Plans, including analysis dataset and TLF specifications
• Perform statistical analyses and interpret statistical results
• Lead study activities when called upon and provide strategic statistical guidance to cross-functional teams
• Present statistical methodology, assumptions, and implications of decisions in clear, non-technical language
• Collaborate with cross-functional teams and adapt as project priorities evolve

Requirements:

• Master's degree in Statistics, Biostatistics, or a related discipline
• 8-10 years of biostatistics experience supporting clinical trials within the pharmaceutical or biotechnology industry
• 3-5 years of Study Lead experience working with cross-functional development teams
• Extensive experience in study design, sample size determination, protocol development, SAP development, efficacy analyses, and preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE)
• Strong knowledge and practical application of advanced statistical methods, including mixed models, longitudinal analyses, and simulation methodologies
• Demonstrated experience performing exploratory statistical analyses to support clinical development and decision-making
• Strong proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling
• Solid SAS programming skills, including QC of critical outputs, efficacy and safety tables, and close collaboration with Statistical Programmers
• Strong knowledge of ICH guidelines and regulatory expectations
• Solid understanding and implementation of CDISC standards for regulatory submissions
• Experience generating ADaM specifications and performing programmatic review of analysis datasets
• Regulatory submission experience (ISS/ISE) strongly desired
• Excellent communication skills with the ability to explain statistical methodology and its implications to both technical and non-technical audiences
• Strong collaborative mindset with a commitment to delivering high-quality work under tight timelines
• Ability to thrive in a dynamic environment, manage ambiguity, and adapt to changing priorities

Benefits:

• Consistent training, development and support
• Significant professional growth
• Professional development opportunities through staff development