Senior Principal Scientist, Biostatistics (Hybrid)

$181,600 - $285,800/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Senior

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Senior Principal Scientist in Biostatistics will lead statistical efforts in drug and vaccine development within the BARDS department. This role involves collaboration with various teams to design and analyze clinical trials, ensuring compliance with regulatory standards and contributing to the strategic planning of product development. The incumbent will also mentor junior staff and engage in innovative statistical research.

Responsibilities

• Serve as a statistical lead in project teams.
• Develop, coordinate, and provide biostatistical support for drug/vaccine projects in Late Development Statistics.
• Interact with Clinical, Regulatory, Statistical Programming, Data Management, and Research Laboratories Scientists to design and analyze clinical trials.
• Lead a team of statistical and/or programming staff assigned to a development project as needed.
• Independently identify and propose solutions for potential problems in clinical trial design and analysis.
• Develop individual protocols and data analysis plans, determining appropriate statistical methodologies.
• Evaluate software for planned analyses and ascertain needs for potential program development.
• Analyze data and interpret results from clinical trials to meet study protocol objectives.
• Prepare reports to communicate clinical trial results to project teams and regulatory agencies.
• Represent biostatistics in regulatory interactions and advisory committee meetings.
• Mentor and guide junior staff in functional activities.

Requirements

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, OR Master's degree with a minimum of 12 years relevant work experience.
• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong scientific leadership in design and analysis of clinical trials.
• Strong project management skills.
• Solid knowledge of statistical and data processing software (e.g., SAS and/or R).
• Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
• Excellent oral and written communication skills and strong leadership in a team environment.
• Demonstrated ability in statistical research activities and application of novel methods to clinical trial development.
• Publications in peer-reviewed statistical/medical journals.

Nice-to-haves

• Understanding of biology of disease and drug discovery and development.
• Immunology experience.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days