Principal Scientist, Biostatistics, Late-Stage Clinical Development
$190.8k - $300.3kFull-time
Merck
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 Responsibilities :
Clinical Trials, Data Management, Data Science, Scientific Modeling, Statistical Analysis, Study Design Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. 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 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. 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 . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. 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 Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.- 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 Job Posting End Date:
10/23/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R414604
- Serves as a statistical lead in project teams.
- Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
- Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and our company Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
- May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
- The incumbent may initially work in a specific disease area such as oncology.
- Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development-
- Is involved in 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.
- Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
- 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.
- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
- May represent biostatistics in regulatory interactions including presentation at advisory committee meetings-
- Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
- Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
- Involved in research activities for innovative statistical methods and applications in clinical trial development.-
- Mentors and guides junior staff in functional activities.
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or a Master's degree with a minimum of 9 years relevant work experience. -
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong project management skills. --
- Solid knowledge of- statistical and data processing software e.g. SAS and/or R.-
- Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-
- Strong oral and written communication skills. Able to function effectively in a team environment.- -
- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.--
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
- Publications in peer reviewed statistical/medical journals.-
- An understanding of biology of disease and drug discovery and development. --
Clinical Trials, Data Management, Data Science, Scientific Modeling, Statistical Analysis, Study Design Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. 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 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. 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 . You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. 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 Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.- 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 Job Posting End Date:
10/23/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R414604
Vacancy posted 9 days ago
Similar jobs that could be interesting for youBased on the Principal Scientist, Biostatistics, Late-Stage Clinical Development in Rahway, NJ vacancy
$190.8k - $300.3k
...Principal Scientist role in Biostatistics leading late-stage clinical development projects. Provides statistical expertise for drug and vaccine development, manages cross-functional teams, and ensures compliance with regulatory requirements throughout the clinical trial...PrincipalWorldwide$173.2k - $272.6k
...and highly motivated Principal Scientist to provide... ...translational and clinical biomarker strategies... ...spanning early through late clinical development. The successful candidate... ...knowledge of biostatistics, bioinformatics, quantitative... ...across multiple stages of clinical...PrincipalFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ14 hours ago- ...Merck seeks a Principal Scientist to lead biomarker strategy development across neuroscience drug development... ...translational and clinical biomarker approaches... ...decisions from early through late-stage development,... ...Working knowledge of biostatistics, bioinformatics, and quantitative...Principal
Merck
Rahway, NJ4 days ago $117k - $184.2k
...Job Description In BARDS (Biostatistics and Research Decision Sciences... ...'s renowned Research and Development division, quantitative scientists, in partnership with other subject... ...programming activities for late-stage drug/vaccine clinical development projects. This may...SuggestedFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift workMerck & Co.
Rahway, NJa month ago$117k - $184.2k
...Senior Scientist role in statistical programming supporting late-stage oncology clinical development within the Biostatistics and Research Decision Sciences department. Responsibilities include developing analysis datasets and reporting deliverables, managing statistical...Suggested$117k - $184.2k
...Job Description In BARDS (Biostatistics and Research Decision Sciences... ...'s renowned Research and Development division, quantitative scientists, in partnership with other subject... ...programming activities for late-stage drug/vaccine clinical development projects. This may...Full timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...Associate Principal Scientist role leading statistical programming for late-stage oncology clinical trials and regulatory submissions. Responsible for developing analysis datasets... ...statistical datasets supporting clinical development, outcomes research, and safety evaluation...PrincipalWorldwide$117k - $184.2k
...Senior Scientist Statistical Programming role in late-stage clinical development supporting drug and vaccine programs. Responsible for designing statistical datasets, developing analysis and reporting deliverables, and leading programming teams across global clinical trials...$142.4k - $224.1k
...DescriptionThe Sterile Product Development (SPD) group is responsible... ...the position of Associate Principal Scientist (R4) supporting the... ...analysis Support both early and late-stage development candidates, including... ..., Chemical Engineering, Clinical Development, Design of...PrincipalFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ3 days ago$255.8k - $402.7k
Job DescriptionJob DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities... ...and respiratory medicines span all phases of clinical development (pre-clinical to post-licensure). The Clinical...PrincipalFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ3 days ago$190.8k - $300.3k
...DescriptionJob Description:Our Scientists are our Inventors.... ...Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within our... ...colleagues in Discovery, Pre-clinical, Early Development,... ...candidates in early- and late-stage development.Responsibilities...PrincipalFull timeFor contractorsLocal areaVisa sponsorshipFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ21 hours ago$190.8k - $300.3k
...Principal Scientist position leading immunology biomarker strategy across clinical development programs. The role combines scientific expertise with cross-functional leadership... ...stakeholders Working knowledge of biostatistics, bioinformatics, and advanced data analytics...Principal$255.8k - $402.7k
...opportunity for a physician-scientist to join our group as a- Principal Scientist (Clinical Director) in... ...Medicine/Early Clinical Development in the Neuroscience... ...discovery scientists and late-stage clinical researchers.... ...discovery research, biostatistics, drug metabolism,...PrincipalFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- ...Role Associate Principal Scientist supporting biologics sterile product development within the Sterile Product Development (SPD) group. Objectives Lead innovative... ...and process development, support early and late-stage candidates, and contribute to regulatory...Principal
Scorpion Therapeutics
Rahway, NJ4 days ago $173.2k - $272.6k
...highly motivated and collaborative scientist/engineer to join our team. This... ...to play a key role in advancing late-stage small molecule programs from development to commercialization while leading... ...initiatives across our global network.The Principal Scientist, Engineering position...PrincipalFull timeContract workFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ14 hours ago- # Associate Principal Scientist, Preclinical DevelopmentRahway, New Jersey, United States of America... ...Job Description**The Sterile Product Development (SPD) group is responsible for... ...data analysisSupport both early and late-stage development candidates, including screening...Principal
Biopharma Careers
Rahway, NJ21 hours ago $282.2k
...Senior Principal Scientist position leading clinical research strategy and execution for oncology drugs across all development phases. Responsible for study design, trial management, regulatory submissions, and cross-functional collaboration within a global healthcare...Principal$190.8k - $300.3k
...and highly motivated Principal Scientist (Director) to serve... ...within Translational Clinical Biomarkers. This... ...immunology clinical development portfolio. The successful... ..., early- and late-stage clinical programs, ensuring... ...knowledge with biostatistics, bioinformatics, and...PrincipalFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$255.8k - $402.7k
...Principal Scientist role overseeing clinical research activities for oncology medicines across all development phases. Responsibilities include study design, trial management, regulatory reporting, and cross-functional collaboration to advance new and marketed drugs through...Principal$142.4k - $224.1k
Job DescriptionIn BARDS (Biostatistics and Research Decision... ...renowned Research and Development division, quantitative scientists, in partnership with other... ...health.The Associate Principal Statistical Programmer,... ...submissions of drug and vaccine clinical development projects....PrincipalFull timeFor contractorsLocal areaWorldwideFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ1 day ago$282.2k
...Senior Principal Scientist leading clinical research strategy and execution for breast cancer oncology medicines across all development phases. Responsible for study design, trial management, regulatory reporting, and cross-functional collaboration to advance investigational...Principal$255.8k - $402.7k
...Merck seeks a Clinical Director (Principal Scientist) to plan and direct clinical research activities for cardiovascular and respiratory medicines across all development phases. The role involves study design, medical oversight, data analysis, regulatory reporting, and...Principal$156.9k - $247k
...role in combination product development (both design and process), commercialization... ...lead several Human Factors scientists to perform and manage human... ...and Activities:The Principal Scientist is responsible for... ..., formulation development, clinical, safety, regulatory,...PrincipalFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ2 days ago$145.48k - $224.1k
...deliverables for global stakeholders, within our Research and Development division.Gather and interpret user requirements for analysis and... ...collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data...PrincipalFull timeFor contractorsSecond jobLocal areaMerck Sharp & Dohme (MSD)
Rahway, NJ2 days ago$117k - $184.2k
Job DescriptionSenior Scientist, Statistical Programming - Rahway, NJ:Provide support to statistical programming activities for late-stage drug/vaccine clinical development projects.Be accountable for the development and execution of statistical analysis and reporting...Full timeFor contractorsLocal areaVisa sponsorshipFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ1 day ago$117k - $184.2k
Job DescriptionOur Research Scientists are our Inventors. Using innovative... ...Process Research & Development (BPR&D) within our Research... ...colleagues in Discovery, Pre-clinical, Early Development, Analytical... ...works on both the early- and late-stage pipeline. This job posting...Full timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ3 days ago$173.2k - $272.6k
...Principal Scientist role in oral formulation development within Merck's Pharmaceutical Sciences and Clinical Supply organization. Leads CMC project teams and formulation development from early-stage first-in-human through market formulation, while driving technology strategy...Principal$142.4k - $224.1k
...Merck's Sterile Product Development group seeks an Associate Principal Scientist to lead biologics formulation and process... ...from preclinical through commercial stages. The role involves designing... ...approaches Support early and late-stage candidates through composition...Principal$142.4k - $224.1k
...Associate Principal Scientist role supporting statistical programming for clinical development and regulatory submissions of drugs and vaccines. Requires advanced SAS expertise, clinical trial programming experience, and leadership of complex projects across global teams...PrincipalWorldwideMerck
Rahway, NJ4 days ago$190.8k - $300.3k
...Merck seeks a Senior Principal Scientist to lead upstream bioprocess development for the Biologics platform. This role combines scientific expertise... ...robust, scalable cell-culture processes for clinical and commercial stage candidates Identify and resolve technical...Principal
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Principal Scientist, Biostatistics, Late-Stage Clinical Development. Be the first to apply!
Related searches