Manager, Biostatistics - Medical Affairs

About the role

This individual will be responsible for statistical support for oncology compounds within Medical Affairs. A typical day may include implementing statistical functions in medical impact plans, planning and executing evidence generation efforts, responding to payer and reimbursement needs, reviewing investigator initiated studies, designing and executing Phase IV studies as the study biostatistician, ensuring statistical rigor in all duties, working with fellow clinical development biostatisticians and programmers to understand clinical trial data, and managing stakeholders.

Responsibilities

• Implement statistical functions in medical impact plans
• Plan and execute evidence generation efforts
• Respond to payer and reimbursement needs
• Review investigator initiated studies
• Design and execute Phase IV studies as the study biostatistician
• Ensure statistical rigor in all duties
• Work with fellow clinical development biostatisticians and programmers to understand clinical trial data
• Manage stakeholders

Requirements

• PhD / DrPH in statistics/biostatistics or related disciplines with >2 years experience in the pharmaceutical/biotech industry or MS degree in statistics/biostatistics with >7 years experience in the pharmaceutical industry as a statistician
• Knowledge of drug discovery/development/life cycle management(LCM) and ability to integrate statistical concepts into drug discovery/development/LCM strategies
• Prior experience or knowledge of oncology is strongly preferred

Qualifications

• Strong interest and motivation in exploring existing clinical trial data for post-hoc analysis and innovative idea investigations
• Experience with clinical trial design, including observational studies
• Exposure to oncology study endpoints and analysis techniques
• Strong communication skills to interpret, explain, and discuss results of complex statistical concepts and analyses to both technical and non-technical audiences
• Desire to present and share results with internal and external stakeholders
• Comfort with providing scientific/statistical input into study design, formulating novel methods to problem solving, and independently developing the statistical analysis plan to implement those solutions
• Authored Statistical Analysis Plans (SAP) and Protocols
• Generated tables, listings, and figures for external communication use in publications/presentations and for internal purposes
• Ability to translate and apply relevant innovative statistical methodology to everyday work
• Education and dissemination of knowledge throughout the organization for areas within the expertise of medical affairs

Skills

• Statistical analysis methodologies
• Experimental and clinical trial design
• Writing code in at least one common statistical software (SAS, R, Python)
• Reading SAS code

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$128,600.00 - $210,000.00 annually

Schedule

Full time