Principal Scientist, Biostatistics

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.

About the role

This position is for a principal scientist in biostatistics. The candidate should have a solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and good clinical trial experience in Phase II/III trials. The knowledge must be sufficient to ensure that sound scientific principles and statistical methods are applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.

This position involves interaction with Medical, Data Coordination, Statistical Programming, our Research & Development Division scientists, and Regulatory staff in designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects. The role may also lead a group of statistical or programming staff assigned to a development project as needed.

Responsibilities

• Develops, coordinates, and provides biostatistical support for drug projects under the supervision of management. Leads a team of staff assigned to the project as needed.
• Involved in late clinical development planning (LDP) to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
• Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions, and carries them out.
• Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for data analysis.
• Participates in Worksheet development, database (collector and view) design meetings to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements.
• Determines the statistical programming needs and organizes the programming activities to ensure that all programs meet analysis requirements, internal standard operating procedures, validation, and external regulatory requirements.
• Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
• Analyzes data and interprets results from experiments to meet objectives of the study protocol. Independently applies and implements basic and complex techniques to these analyses.
• Prepares oral and written reports to effectively communicate results of clinical trials to the project team, company management, regulatory agencies, or individual investigators.
• Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, or investigators. Ensures the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participates with management in discussions with corresponding technical personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Collaborates in publication of research results in areas of applications.
• Independently conducts research on statistical methodology, pursues solutions to various technical problems, adapts known methods, and develops new methods.
• Maintains technical skills and increases own knowledge of new methods or areas of applications by reading journals and attending professional society meetings. Presents own research at meetings and seminars.
• Communicates with statisticians outside the company concerning technical problems.
• Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical groups, department research efforts, and other committee work, as needed.

Requirements

• Ph.D. (preferred) or MS in Biostatistics or Statistics.
• With an MS, a minimum of 9 years relevant work experience; with a Ph.D., a minimum of 6 years relevant work experience.

Preferred Experience and Skills

• Scientific leadership in design and analysis of clinical trials.
• Experience with regulatory filing for approval of drug/vaccine products; regulatory submission experience strongly preferred.
• Prior experience with respiratory and immunology disease areas.

Skills

• Required: Biostatistics, Clinical Trial Management, Clinical Trials, Clinical Trials Analysis, Computing Software, Data Management, Data Science, Numerical Analysis, Regulatory Compliance, Regulatory Requirements, Scientific Leadership, Scientific Modeling, Standard Operating Procedure (SOP), Statistical Analysis.
• Preferred: Experience in leading teams and collaborating across multidisciplinary groups.

Pay

The salary range for this role is $190,800.00 - $300,300.00. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• 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.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule

• Travel Requirements: 10%
• Flexible Work Arrangements: Hybrid