Senior Principal Scientist, Biostatistics

MSD • Rahway, NJ

6d • Hybrid

About The Position

Within BARDS (Biostatistics and Research Decision Sciences), a department in Research and Development, this role provides statistical leadership and biostatistical support for drug and vaccine projects in Late Development Statistics. The position partners with clinical, regulatory, statistical programming, data management, research laboratory, academic research, contract research, and external statistical stakeholders to design and analyze clinical trials and coordinate statistical activities.

The role leads statistical planning and execution within cross-functional product development teams, contributes to early- and late-stage clinical development planning, and ensures study designs address program objectives and worldwide regulatory and marketing needs. It develops protocols and analysis plans, selects appropriate statistical methods, identifies and resolves potential technical problems, evaluates software and potential needs for novel program development, analyzes trial data, interprets results, and communicates findings to project teams, management, regulators, and investigators. The position may lead statisticians and statistical programming staff, represents biostatistics in regulatory interactions and advisory committee meetings, and responds to questions about trial design, analysis, and interpretation.

The role also leads research into innovative statistical methods and their clinical trial applications, collaborates on publications, mentors junior staff, and contributes to departmental recruiting, training, and committee activities. The position is based primarily in Rahway, New Jersey, with a hybrid work arrangement and 10% travel.

Requirements

• PhD or equivalent degree in statistics, biostatistics, or a related discipline and at least 9 years of relevant work experience; or a master's degree and at least 12 years of relevant work experience.
• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong scientific leadership in the design and analysis of clinical trials.
• 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 statistical research activity 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, develop, coordinate, and provide biostatistical support for related drug and vaccine projects in Late Development Statistics.
• Lead interactions with clinical, regulatory, statistical programming, data management, research laboratory scientists, academic research organizations, contract research organizations, and external statistical consultants.
• Lead biostatistics in early- or late-clinical-development planning to ensure study designs align with program objectives and worldwide regulatory and marketing needs.
• Identify and anticipate technical or other potential problems in the design, conduct, and analysis of clinical trials, propose solutions, and carry them out.
• Develop individual protocols and data analysis plans and determine appropriate statistical methodology for analyses.
• As needed, lead statisticians and statistical programming staff to ensure programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
• Evaluate statistical software for planned analyses and identify potential needs for development of novel statistical programs or methodology.
• Analyze clinical-trial data and interpret results in accordance with study protocol objectives, applying 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 with investigators about proposed or ongoing studies.
• Lead research activities involving innovative statistical methods and applications in clinical trial development.
• Collaborate on publication of research results.
• Mentor and guide junior staff in functional activities.
• Participate in departmental recruiting and training, provide statistical training for non-statistical groups, and contribute to committee work as needed.

Benefits

• Medical, dental, vision, healthcare, and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an 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