Senior Principal Scientist, Biostatistics

Merck; New Jersey; On-site; USD 140,000 - 190,000; Full time

Job summary

Merck in New Jersey is seeking an experienced senior biostatistician to act as statistical lead on late-stage drug/vaccine projects. You will design and analyze clinical trials, coordinate statistical activities across Clinical, Regulatory, and Data Management teams, and interact with external CROs and consultants.

The role requires PhD or equivalent with extensive experience, or a Master’s with substantial experience, and strong leadership, communication, and programming skills (SAS, R) to

Qualifications

• PhD or equivalent with 9+ years relevant work experience, or Master’s with 12+ years.
• 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 R.
• Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
• Excellent oral and written communication skills and leadership in a team environment.
• Publications in peer reviewed statistical/medical journals.

Responsibilities

• Serve as statistical lead in cross-functional teams for product development planning and execution.
• Lead a team of statisticians and/or programming staff on development projects as needed.
• Guide biostatistics in early to late clinical development to align with program objectives and regulatory needs.
• Identify and propose solutions to design/conduct/analysis problems in trials.
• Develop protocols and data analysis plans, choosing appropriate statistical methods.
• Evaluate software adequacy and potential need for novel methods.
• Analyze trial data and interpret results to meet study objectives.
• Prepare oral and written reports for project teams, management, regulators and investigators.

Skills

Biostatistics

Clinical Development

Data Management

Data Processing

Data Science

New Program Development

Project Management

Regulatory Requirements

Statistical Analysis

Statistical Methods

Statistical Programming

Strategic Thinking

Study Design

Teamwork

Written Communication

Education

PhD in statistics/biostatistics or related

Master's degree in statistics/biostatistics or related

Tools

SAS

R

Job description

Role 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 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.

Primary activities:

• 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.
• 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

Education and Minimum Requirement:

• 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.

Required Skills and 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 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 Skills and Experience:

• An understanding of biology of disease and drug discovery and development.

#EligibleforERP

BARDS2020

Required Skills:

• Biostatistics
• Clinical Development
• Data Management
• Data Processing
• Data Science
• New Program Development
• Project Management
• Regulatory Requirements
• Statistical Analysis
• Statistical Methods
• Statistical Programming
• Strategic Thinking
• Study Design
• Teamwork
• Written Communication