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Job description
Job Description
Job Description 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. This position is for a principal scientist in biostatistics. The candidate should have a solid knowledge of statistical methodology, experimental design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ III trials. The knowledge must be sufficient to ensure that sound scientific principles and statistical methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions. This position involves interaction with Medical, Data Coordination, Statistical Programming, our Research & Development Division scientists and Regulatory staffs in designing and analyzing clinical trials and coordinating the statistical activities for clinical trial projects; and may lead a group of statistical or programming staff assigned to a development project as needed. More specifically, Develops, coordinates, and provides biostatistical support for drug projects under the supervision of management. Lead a team of staff assigned to the project as needed. This includes the following activities:
Responsibilities
Is involved in late clinical development planning (LDP) 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 data analysis.
Participates in Worksheet development, database (collector and view) design meetings to ensure that the data evaluated are free of bias, contain maximum information (minimum variance), and satisfy analysis requirements.
Determines the statistical programming needs and organizes the programming activities to ensure that all programs meet analysis requirements, internal standard operating procedures, validation, 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 experiments to meet objectives of the study protocol.
Independently applies and implements basic and complex 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.
Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, or investigators.
Responsible for ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
Participates with management in discussions with corresponding technical personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
Collaborates in publication of research results in areas of applications.
Independently conducts research on statistical methodology, pursues solutions to various technical problems, adapts known methods and develops new methods.
Maintains technical skills and increases own knowledge of new methods or areas of applications by reading journals and attending professional society meetings.
Presents own research at meetings and seminars.
Communicates with statisticians outside our Company's concerning technical problems.
Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical groups, department research effort, and other committee works, etc., as needed.
Position Qualifications
Education Minimum Requirement: Ph.D. (preferred) or MS in Biostatistics or Statistics
Required Experience and Skills: With a MS, a minimum of 9 years relevant work experience; with a Ph.D., a minimum of 6 years relevant work experience.
Preferred Experience and Skills: Scientific leadership in design and analysis of clinical trials; Experience with regulatory filing for approval of drug/vaccine products; Regulatory submission experience strongly preferred; Prior experiences with respiratory and immunology disease areas are desired.
BARDS2020 #eligibleforERP
Required Skills
Biostatistics
Clinical Trial Management
Clinical Trials
Clinical Trials Analysis
Computing Software
Data Management
Data Science
Numerical Analysis
Regulatory Compliance
Regulatory Requirements
Scientific Leadership
Scientific Modeling
Standard Operating Procedure (SOP)
Statistical Analysis
Salary & Benefits
The salary range for this role is $190,800.00 - $300,300.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Medical, dental, vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Employee Status: Regular
Relocation: Domestic
VISA Sponsorship: Yes
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Job Posting End Date: 09/29/2026
Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts
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Worksite address
rahway, NJ, 07065, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.