Senior Principal Scientist, Biostatistics
Merck & Co.
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Job summary
Merck & Co. in Rahway, NJ, seeks a senior biostatistician to serve as statistical lead on drug/vaccine development programs. You will design analyses, lead cross-functional teams, and interact with Clinical, Regulatory, and external partners to ensure robust study outcomes.
You will mentor statisticians, drive methodological advances, and contribute to publications while navigating global regulatory expectations and development timelines.
Qualifications
- 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.
Responsibilities
- Serves as 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 company labs in designing and analyzing clinical trials.
- Interacts with Academic Research Organization, Contract Research Organization and external statistical consultants.
- Lead a team of statistical and/or programming staff on development projects as needed.
- Lead biostatistics in early or late clinical development planning to align with program objectives and regulatory needs.
- Independently identifies and anticipates problems in design, conduct, and analysis and proposes solutions.
- Develops protocols and data analysis plans and determines appropriate statistical methodology.
- May lead a team to ensure programs meet analysis requirements and regulatory standards.
- Evaluates software for planned analyses and needs for potential new methods.
- Analyzes data and interprets results to meet study objectives and communicates results to stakeholders.
- Represent biostatistics in regulatory interactions and advisory committee meetings.
Skills
Education
Tools
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.
- 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.
- 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
- 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 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.
- An understanding of biology of disease and drug discovery and development.
- 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
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
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.
USA - New Jersey - Rahway
Where required by law, the compensation range for this role is provided below.
$210,400.00 - $331,100.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
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.
Regular
Domestic
No
10%
Hybrid
Not Indicated
No
n/a
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