Principal Scientist, Biostatistics

Merck & Co.; Rahway (NJ); On-site; USD 190,800 - 300,300; Full time

Benefits offered by this job

Medical insurance

401(k) retirement plan

Job summary

Merck & Co. in the BARDS department seeks a Principal Scientist in Biostatistics to lead biostatistical support for drug projects and guide project teams through late clinical development. You will design analyses, manage a team, and ensure regulatory readiness across worldwide submissions.

The role requires Ph.D. (preferred) or MS in Biostatistics or Statistics with substantial trial experience and expertise in regulatory expectations.

Qualifications

• Ph.D. (preferred) or MS in Biostatistics or Statistics.
• MS: minimum 9 years relevant work experience; Ph.D.: minimum 6 years relevant work experience.
• Experience in design and analysis of clinical trials; regulatory filing experience preferred; exposure to respiratory/immunology areas.

Responsibilities

• Develops biostatistical support for drug projects under management.
• Leads a team of staff on projects as needed.
• Participates in late development planning to align with regulatory and marketing needs.
• Identifies and solves design/analysis problems in trials.
• Develops protocols and data analysis plans; selects appropriate statistical methods.
• Interacts with data collection and database design to ensure unbiased, informative data.
• Plans statistical programming needs and ensures regulatory compliance.
• Assesses software suitability for analyses and potential novel methods.
• Analyzes experimental results and communicates findings to teams and regulators.
• Prepares oral and written reports for project teams, regulators, and investigators.
• Responds to study design/analysis questions from monitors and agencies.
• Ensures accuracy of Statistical Review Aids submitted to agencies.
• Collaborates with regulators and investigators on studies.
• Engages in publication of research results.

Skills

Biostatistics

Clinical Trial Management

Clinical Trials Analysis

Regulatory Compliance

Data Management

Statistical Analysis

SOP/Quality

Scientific Leadership

Education

Biostatistics or Statistics (MS/PhD)

Job description

Job Description

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.

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 with 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.

Responsibilities

• Develops, coordinates, and provides biostatistical support for drug projects under the supervision of management.
• Lead a team of staff assigned to the project as needed.
• Is 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, our Company's 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.
• Responsible for ensuring 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 our Company's concerning technical problems.
• Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non‑statistical groups, department research effort, and other committee works, etc., as needed.

Qualifications

• Education Minimum Requirement: Ph.D. (preferred) or MS in Biostatistics or Statistics.
• Experience: With a 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 experiences with respiratory and immunology disease areas are desired.
• Required Skills: 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.

Salary & Benefits

Salary Range: $190,800.00 - $300,300.00

We offer a comprehensive package of benefits. Available benefits include 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.

Location Requirements

San Francisco Residents Only. Los Angeles Residents Only.

Equal Employment Opportunity Statement

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

Requisition ID: R405317

Job Posting End Date: 08/7/2026