Senior Principal Scientist, Biostatistics (Hybrid)
USA - New Jersey - Rahway
Job Description
Position Description:
Senior Principal Scientist, Biostatistics (Hybrid)
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
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 our company's 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.
The incumbent may initially work in a specific disease area.
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'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 …
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Hybrid Hybrid work model
Benefits/PerksFlexible work arrangements Hybrid work Hybrid work model Inclusive environment Insurance Meetings Paid holidays Retirement benefits Sick Days Vacation
Tasks- Collaboration
- Communicate results to stakeholders
- Communication
- Data Analysis
- Data Management
- Develop protocols and analysis plans
- Innovation
- Interprets results from clinical trials
- Leadership
- Mentor junior staff
- Planning
- Presentation
- Project management
- Represent biostatistics in regulatory interactions
- Statistical analysis
- Statistical lead in project teams
- Statistical programming
- Strategic Planning
Analysis Biology Biostatistics Business Operations Clinical Clinical Development Clinical trials Collaboration Commercial Communication Cross-functional Teams Data Data analysis Data Management Design Drug Discovery Experimental Design Immunology Innovation Leadership Management Manufacturing Marketing Planning Presentation Product Development Programming Project Management Protocol Development R Regulatory Regulatory Compliance Regulatory requirements Research Research and development SAS Scientific Leadership Statistical analysis Statistical Methodology Statistical methods Statistical Programming Statistical Research Statistical techniques Statistics Strategic planning Study Design Team Leadership Technical Training Vaccines
Experience9 years
EducationBiology Biostatistics Business Equivalent Equivalent degree Immunology Management Marketing Ph.D. Statistics
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9