Merck · 5 hours ago
Principal Scientist, Biostatistics
USA - New Jersey - Rahway
Full-time
Hybrid
Senior Level, Lead/Staff
$191K/yr - $300K/yr
6+ years expMerck is a leading company in the field of drug and vaccine development, seeking a Principal Scientist in Biostatistics to contribute to their research and development division. The role involves leading statistical efforts in clinical trial design, analysis, and interpretation to support drug and vaccine projects.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
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
Qualification
Required
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
Preferred
Publications in peer-reviewed statistical/medical journals
An understanding of biology of disease and drug discovery and development
Benefits
Medical
Dental
Vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
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