Manager, Biostatistics - Medical Affairs

About the role

This individual will be responsible for statistical support for oncology compounds within Medical Affairs. A typical day includes implementing the statistical function's role in oncology compounds' 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, working with clinical development biostatisticians and programmers to deeply dive into clinical trial data, managing stakeholders, learning about oncology and the company's compounds, developing Regeneron cultural understanding, and gaining general industry knowledge.

Responsibilities

• Implement the statistical function’s role in oncology compounds' medical impact plans
• Plan and execute evidence generation efforts, including post-hoc analysis with innovative analytical approaches
• 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 deeply dive into clinical trial data
• Manage stakeholders
• Learn about oncology and the company's compounds
• Develop Regeneron cultural understanding
• Gain general industry knowledge

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
• Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment
• Demonstrated critical thinking skills, time management skills, and effective communication skills
• Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
• Ability to write code in at least one common statistical software is required (i.e. SAS, R, Python)
• Ability to read SAS code is required

Qualifications

• 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
• Prior experience or knowledge of oncology is strongly preferred
• Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment
• Demonstrated critical thinking skills, time management skills, and effective communication skills
• Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
• Ability to write code in at least one common statistical software is required (i.e. SAS, R, Python)
• Ability to read SAS code is required

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

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

Pay

$128,600.00 - $210,000.00 annually

Schedule

Not specified