Principal Scientist, Biostatistics, Late-Stage Clinical Development

Merck; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Merck is seeking a senior biostatisticist to lead statistical activities in late-stage development and coordinate across Clinical, Regulatory, and Data Management teams. You will design analyses, develop protocols, and ensure regulatory alignment for trials in oncology and other areas.

The role requires PhD or equivalent with extensive experience in statistics, SAS/R, and a strong track record in clinical trial development and regulatory interactions.

Qualifications

• PhD or equivalent in statistics/biostatistics or related field with 6+ years experience (PhD) or 9+ years (Master).
• Strong knowledge of statistical methodologies and experimental design.
• Experience with regulatory expectations for global trials (II–V).

Responsibilities

• Serve as statistical lead in cross-functional project teams.
• Provide leadership and support for late-development drug/vaccine projects.
• Interact with Clinical, Regulatory, Data Management and other teams to design and analyze trials.
• May interact with CROs or external statisticians.
• Mentor junior staff and guide statistical programming teams.

Skills

Statistical methods

Experimental design

Project management

SAS

R

Regulatory experience

Clinical trials

Communication

Learning & detail orientation

Education

PhD in statistics/biostatistics

Master's degree with 9+ years experience

Tools

SAS

R

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.

Responsibilities

• Serves as a statistical lead in project teams.
• Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
• Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and our company Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
• May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
• The incumbent may initially work in a specific disease area such as oncology.

Primary Activities

• Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development.
• Is involved in clinical development planning 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 analysis.
• Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
• May 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.
• 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 clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical 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, and/or investigators.
• May represent biostatistics in regulatory interactions including presentation at advisory committee meetings.
• Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
• Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
• Involved in research activities for innovative statistical methods and applications in clinical trial development.
• Mentors and guides junior staff in functional activities.

Education And Minimum Requirement

• 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.

Required Skills And 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 and/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.
• Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Skills And Experience

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

Required Skills

Clinical Trials, Data Management, Data Science, Scientific Modeling, Statistical Analysis, Study Design.

US And Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. If you need an accommodation during the application or hiring process, please contact us.

Requirements

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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts.

Salary and Compensation

The salary range for this role is $190,800.00 - $300,300.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.

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.

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Yes

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

09/26/2026

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R414604