Manager, Biostatistics - Medical Affairs

Regeneron Pharmaceuticals • Sleepy Hollow, WY

31d

About The Position

Regeneron is seeking a Manager, Biostatistics to join our team! This individual will be responsible for statistical support for oncology compounds within Medical Affairs. In this role, a typical day may include: As part of a collaborative medical affairs team, you will implement the statistical function’s role in the oncology compounds’ medical impact plans. Together with medical directors, HEOR, medical writing, market access, and other colleagues within medical affairs, you will plan and execute evidence generation efforts, such as post-hoc analysis with innovative analytical approaches, respond to payer and reimbursement needs, review investigator initiated studies, and design and execute Phase IV studies as the study biostatistician, and ensure statistical rigor in all these duties. You will also work with fellow clinical development biostatisticians and programmers to deep dive into the clinical trial data for comprehensive understanding. You will be responsible for following departmental guidelines of collaboration, innovation, and intrinsic motivation. Working in a dynamic team with a wide range of interfaces, the role requires both strategic and operational skills combining innovative statistical thinking with a strong sense of business acumen, and excellent communication and interpersonal skills. Your manager will work with you to manage stakeholders, learn about oncology and the company’s compounds, develop Regeneron cultural understanding, and general industry knowledge. This role might be for you if you have: 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 translate and apply relevant innovative statistical methodology to everyday work. Educate and disseminate knowledge throughout the organization for areas within the expertise of medical affairs.

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
• 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

Nice To Haves

• Prior experience or knowledge of oncology is strongly preferred
• 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

Responsibilities

• Implement the statistical function’s role in the oncology compounds’ medical impact plans
• Plan and execute evidence generation efforts, such as post-hoc analysis with innovative analytical approaches, respond to payer and reimbursement needs, review investigator initiated studies, and design and execute Phase IV studies as the study biostatistician, and ensure statistical rigor in all these duties
• Work with fellow clinical development biostatisticians and programmers to deep dive into the clinical trial data for comprehensive understanding
• Follow departmental guidelines of collaboration, innovation, and intrinsic motivation
• Provide scientific/statistical input into study design, formulating novel methods to problem solving, and independently developing the statistical analysis plan to implement those solutions
• Author Statistical Analysis Plans (SAP) and Protocols
• Generate tables, listings, and figures for external communication use in publications/presentations and for internal purposes
• Translate and apply relevant innovative statistical methodology to everyday work
• Educate and disseminate knowledge throughout the organization for areas within the expertise of medical affairs

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree