Senior Principal Scientist, Biostatistics

MSD

7d • $210,400 - $331,100 • Hybrid

About The Position

In BARDS (Biostatistics and Research Decision Sciences), a department within the Research and Development division, quantitative scientists partner with other subject matter experts to apply scientific methodologies and tools supporting the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines. The Senior Principal Scientist, Biostatistics serves as a statistical lead for projects in Late Development Statistics and provides biostatistical support across drug and vaccine development.

The role leads cross-functional statistical planning and execution, clinical trial design and analysis, statistical research, and interactions with internal teams, external research organizations, consultants, regulators, and investigators. It may lead statisticians and programming staff, mentor junior colleagues, and communicate study results through reports, presentations, publications, and regulatory interactions.

Requirements

• PhD or equivalent degree in statistics, biostatistics, or a related discipline and a minimum of 9 years of relevant work experience; alternatively, a master's degree and a minimum of 12 years of relevant work experience.
• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong scientific leadership in clinical trial design and analysis.
• Strong project management skills.
• Solid knowledge of statistical and data-processing software, such as SAS and 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 and application of novel methods to clinical trial development.
• Publications in peer-reviewed statistical or medical journals.
• Ability to learn, be proactive and motivated, and consistently focus on details and execution.

Nice To Haves

• Understanding of disease biology and drug discovery and development.

Responsibilities

• Serve as statistical representative and lead in cross-functional teams for strategic planning and execution of product development.
• Lead and coordinate biostatistical support for related drug and vaccine projects in Late Development Statistics.
• Lead interactions with Clinical, Regulatory, Statistical Programming, Data Management, and other Research Laboratories scientists on clinical trial design, analysis, and statistical activities.
• Interact with academic research organizations, contract research organizations, and external statistical consultants.
• Lead statistical and/or programming staff assigned to a development project as needed.
• Lead biostatistics input into early- or late-clinical-development planning to ensure study designs align with program objectives and worldwide regulatory and marketing needs.
• Identify potential technical and other problems in clinical trial design, conduct, and analysis; propose and implement solutions.
• Develop individual protocols and data analysis plans and determine appropriate statistical methodologies.
• Ensure statistical programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements when leading a team.
• Evaluate software suitability for planned analyses and identify potential development needs for novel statistical methods.
• Analyze clinical trial data and interpret results, independently applying and implementing basic and complex statistical techniques.
• Prepare oral and written reports communicating clinical trial results to project teams, company management, regulatory agencies, and investigators.
• Represent biostatistics in regulatory interactions, including presentations at advisory committee meetings.
• Respond to questions about study design, analysis, and interpretation from clinical monitors, regulatory agencies, and investigators.
• Participate with management in discussions with scientific personnel at regulatory agencies and investigators about proposed or ongoing studies.
• Lead research activities on innovative statistical methods and applications in clinical trial development.
• Collaborate on publications of research results.
• Mentor and guide junior staff in functional activities.
• Participate in departmental activities, including recruiting and training statisticians, providing statistical training to non-statistical groups, and committee work as needed.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.

What This Job Offers

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