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Merck · 18 hours ago

Senior Principal Scientist, Biostatistics

Rahway, NJ

Full-time

Hybrid

Senior Level, Lead/Staff

$206K/yr - $325K/yr

9+ years exp

Merck is a leading company in the pharmaceutical industry, focused on the development of medical drugs and vaccines. The Senior Principal Scientist in Biostatistics will serve as a statistical lead on project teams, providing biostatistical support and collaborating with various departments to design and analyze clinical trials.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

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 Scientists from our Research & Development Division 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

The incumbent may initially work in a specific disease area

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, our Company's 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

BiostatisticsClinical DevelopmentStatistical AnalysisStatistical ProgrammingRegulatory ComplianceData AnalysisScientific LeadershipProject ManagementData ManagementNumerical AnalysisScientific ModelingStrategic PlanningClinical TrialsClinical Trial Management ProcessesClinical Trials Analysis

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