Senior Principal Scientist, Biostatistics

Merck•Rahway, NJ

5d•$210,400 - $331,100•Hybrid

About The Position

Within BARDS (Biostatistics and Research Decision Sciences), a department in the Research and Development division, quantitative scientists partner with subject matter experts to apply scientific methodologies and tools supporting the discovery, development, regulatory approval, manufacturing, and marketing of medicines and vaccines. The Senior Principal Scientist, Biostatistics serves as a statistical lead for drug and vaccine projects in Late Development Statistics, supporting project teams and coordinating biostatistical activities across functions and with external partners. The role leads statistical strategy and execution in cross-functional product-development teams, contributes to clinical development planning, and ensures trial designs align with program objectives and global regulatory and marketing needs. It develops protocols and analysis plans, selects and applies statistical methods, analyzes and interprets clinical-trial data, and communicates findings to internal teams, management, regulatory agencies, and investigators. The role may lead statistical and programming staff, represents biostatistics in regulatory interactions, contributes to innovative statistical research and publications, and mentors junior colleagues. The position requires a PhD or equivalent degree in statistics, biostatistics, or a related discipline and at least 9 years of relevant experience, or a master’s degree and at least 12 years of relevant experience. The primary location is Rahway, New Jersey, and the work arrangement is hybrid. The role has 10% travel requirements and domestic relocation is listed. Visa sponsorship is not available.

Requirements

PhD or equivalent degree in statistics, biostatistics, or a related discipline and a minimum of 9 years of relevant work experience, or 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 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 Phase V.
Excellent oral and written communication skills and strong leadership in a team environment.
Demonstrated ability in statistical research and in applying 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 lead and representative on project and cross-functional teams, contributing to strategic planning and execution of product development.
Lead, develop, coordinate, and provide biostatistical support for drug and vaccine projects in Late Development Statistics.
Lead interactions with Clinical, Regulatory, Statistical Programming, Data Management, company research scientists, academic research organizations, contract research organizations, and external statistical consultants.
Lead statistical and/or programming staff assigned to development projects as needed.
Lead biostatistics input into early- or late-stage clinical development planning and ensure study designs support program objectives and worldwide regulatory and marketing needs.
Identify and anticipate technical or other potential problems in clinical-trial design, conduct, and analysis; propose and implement solutions.
Develop protocols and data analysis plans and determine appropriate statistical methods.
Ensure statistical programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
Evaluate software for planned analyses and identify needs for development of programs implementing novel statistical methods.
Analyze clinical-trial data and interpret results, applying basic and complex statistical techniques to meet study objectives.
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 queries about study design, analysis, and interpretation from clinical monitors, regulatory agencies, and investigators.
Participate with management in discussions with regulatory-agency scientific personnel and investigators about proposed or ongoing studies.
Lead research activities on innovative statistical methods and applications in clinical-trial development and collaborate on publication 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 serving on committees as needed.