Senior Principal Biostatistics Lead, Clinical Trials

Merck; Upper Gwynedd Township (Montgomery County); Hybride; USD 210 000 - 331 000; Plein temps

Résumé du poste

Merck in Rahway, NJ seeks a senior Biostatistician within BARDS to lead biostatistics in late-stage clinical development and support regulatory interactions. You will design trials, supervise statisticians, and drive methodological innovation in collaboration with cross-functional teams.

Applicants should have a PhD or equivalent with extensive experience, or a Master’s with substantial experience, plus strong SAS and R skills, and a publication track record.

Qualifications

• PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or Master’s degree with a minimum of 12 years relevant work experience.
• Solid knowledge of statistical analysis methodologies and experimental design.
• Strong leadership and project management skills.
• Solid knowledge of statistical and data processing software e.g. SAS and R.
• Knowledge of worldwide regulatory requirements and clinical trial expertise from phase II to V.
• Excellent oral and written communication and leadership in a team environment.
• Publications in peer reviewed statistical/medical journals.
• Ability to learn, be proactive and motivated, and consistently focus on details and execution.

Responsabilités

• 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 our Company 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, Contract Research Organization 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, our Company 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.
• Mentuors 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

Connaissances

Biostatistics

Clinical Development

Data Management

Data Processing

Data Science

Project Management

Regulatory Requirements

Statistical Analysis

Statistical Methods

Statistical Programming

Leadership

Study Design

Written Communication

Formation

PhD or equivalent in statistics/biostatistics or related discipline

Master’s degree in statistics/biostatistics or related discipline

Outils

SAS

R

Description du poste

Merck in Rahway, NJ seeks a senior Biostatistician within BARDS to lead biostatistics in late-stage clinical development and support regulatory interactions. You will design trials, supervise statisticians, and drive methodological innovation in collaboration with cross-functional teams.

Applicants should have a PhD or equivalent with extensive experience, or a Master’s with substantial experience, plus strong SAS and R skills, and a publication track record.