Principal Scientist, Biostatistics

Merck•North Wales, PA

1d•Hybrid

About The Position

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Principal Scientist, Biostatistics Are you passionate about biostatistics and eager to make a significant impact in the field of drug and vaccine development? Join our company, where we are at the forefront of research, delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals. As a Principal Scientist in Biostatistics, you will play a critical role in our research & development division, contributing to the design, analysis, and interpretation of clinical trials.

Requirements

PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or a Master’s degree with a minimum of 9 years relevant work experience.
Solid knowledge of statistical analysis methodologies and experimental design.
Strong project management skills.
Solid knowledge of statistical and data processing software (e.g., SAS or R).
Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
Strong oral and written communication skills. Able to function effectively in a team environment.
Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
Solid knowledge and strong interest in exploring applications of AI/ML to the analysis, validation, and reporting of clinical trial data.
Demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Nice To Haves

Publications in peer-reviewed statistical/medical journals.
An understanding of biology of disease and drug discovery and development.

Responsibilities

Serve as a statistical lead in project teams.
Develop, coordinate, and provide biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
Interact with Clinical, Regulatory, Statistical Programming, Data Management, and other Research & Development Division Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
Interact with Academic Research Organization (ARO), Contract Research Organization (CRO), and external statistical consultants.
Serve as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development.
Participate in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
Independently identify and anticipate technical or other potential problems arising in the design, conduct, and analysis of clinical trials, propose solutions, and carry them out.
Develop individual protocols and data analysis plans and independently determine appropriate statistical methodology for analysis.
Participate in database design meetings to ensure that the data evaluated are of high quality and satisfy analysis requirements.
Lead a team of statisticians and statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
Evaluate the appropriateness of available software for planned analyses and ascertain needs for potential program development of novel statistical methodology.
Analyze data and interpret results from clinical trials to meet objectives of the study protocol. Independently apply and implement basic and complex statistical techniques to these analyses.
Prepare oral and written reports to effectively communicate results of clinical trials to the project team, Company Management, regulatory agencies, or individual investigators.
Provide responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
Represent biostatistics in regulatory interactions including presentation at advisory committee meetings.
Plan and ensure the accuracy of Statistical Review Aids submitted to regulatory agencies.
Participate with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
Engage in research activities for innovative statistical methods and applications in clinical trial development.
Mentor and guide junior staff in functional activities.

Benefits

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays, vacation, and compassionate and sick days

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