Manager, Biostatistics

About the role

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. The incumbent will work with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions.

Responsibilities

• Interacts with Medical and Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statisticians and AI scientists, Statistical Programming, Data Management, Medical Writing, and others to design methodologies to advance clinical development.
• Develops any research proposals or protocols if needed and statistical analysis plans and determines appropriate statistical methodology for data analysis.
• Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
• Analyzes data and interprets results from clinical trials and of data from non-trial sources (RWD) to facilitate program-level decision making.
• Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies.
• Co-presents findings to management.
• Is involved in research activities for innovative statistical methods and applications in clinical trial development (e.g., external control arms, hybrid designs, master protocols), with expectation of publications and methodological contributions, as well as providing training to non-statisticians.

Requirements

• PhD or equivalent degree in statistics/biostatistics with > 2 years’ experience or related disciplines with internship experience, or MS degree in statistics/biostatistics with >7 years’ experience in the pharmaceutical industry as a statistician.
• Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment.
• Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills.
• Solid knowledge of statistical analysis methodologies, experimental and clinical trial design.
• Expertise in statistical software such as R or SAS is required.
• Experience with or strong willingness to learn LLM agents (e.g., Claude, Gemini) for statistical workflows preferred.

Qualifications

• PhD or equivalent degree in statistics/biostatistics with > 2 years’ experience or related disciplines with internship experience, or MS degree in statistics/biostatistics with >7 years’ experience in the pharmaceutical industry as a statistician.

Skills

• Statistical analysis methodologies, experimental and clinical trial design.
• Expertise in statistical software such as R or SAS.
• Experience with or strong willingness to learn LLM agents (e.g., Claude, Gemini) for statistical workflows.

Benefits

• Annual bonuses or other incentive plans.
• Equity awards.
• Pension or retirement benefits.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits (e.g. medical, dental, vision, life and disability).
• Paid time off.
• Family support benefits.

Pay

$128,600.00 - $210,000.00 annually

Schedule

Hybrid; 4 days per week on site