Merck · 17 hours ago
Senior Principal Statistician
Rahway, NJ
Full-time
Onsite
Senior Level, Lead/Staff
$210K/yr - $331K/yr
9+ years expMerck is a distinguished company within the pharmaceutical industry, seeking a Senior Principal Statistician. The role involves leading biostatistical support for drug and vaccine projects, collaborating with cross-functional teams, and mentoring junior staff to ensure effective statistical methodologies in clinical trials.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Serves as a statistical lead in project teams
Lead, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Late Development Statistics
Lead the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects
Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants
Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
Lead a team of statistical and/or programing staff assigned to a development project as needed
Lead biostatistics in early or late 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
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, Management, regulatory agencies, or individual investigators
Represent biostatistics in regulatory interactions including presentation at advisory committee meetings
Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators
Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies
Lead research activities for innovative statistical methods and applications in clinical trial development
Collaborates in publication of research results in areas of applications
Mentors and guides junior staff in functional activities
Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee works as needed
Qualification
Required
PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a master's degree with a minimum of 12 years relevant work experience
Solid knowledge of statistical analysis methodologies and experimental design
Strong scientific leadership in design and analysis of clinical trials
Strong project management skills
Solid knowledge of statistical and data processing software e.g. SAS and/or R
Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V
Excellent oral and written communication skills and strong leadership in a team environment
Demonstrated ability in statistical research activities and in application of novel methods to clinical trial development
Publications in peer reviewed statistical/medical journals
Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution
Preferred
An understanding of biology of disease and drug discovery and development; experience in late-stage oncology development preferred, hematology a plus
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
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2026-01-22
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