Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Scientist, Biostatistics, CMC Statistics

$117k - $184.2k

Merck & Co.

Job Overview In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within the company’s Research and Development division, quantitative scientists collaborate with subject matter experts to apply scientific methodologies and tools. The goal is to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines. Responsibilities Provide biostatistical leadership and support for drug development projects in the CMC area. Coordinate with internal groups such as analytical, formulation, project management, regulatory, statistical programming, data management, and manufacturing divisions. Serve as the statistical lead in project teams, managing multiple projects independently and supporting scientific protocols. Represent the statistical function in cross‑functional teams and contribute to department and therapeutic area goals. Participate in professional societies and technical associations. Primary Activities Act as the statistical representative and lead in cross‑functional teams for strategic planning and product development execution. Develop data analysis plans and select appropriate statistical methodologies for CMC‑related studies. Prepare reports to communicate results to project teams, management, regulatory agencies, or scientists. Mentor junior staff. Education and Minimum Requirements

  • PhD or equivalent degree in statistics, biostatistics, or a related field.
  • Or a Master’s degree in Statistics or Applied Statistics with at least three years of relevant experience.
Required Skills and Experience Knowledge of statistical analysis methodologies and experimental design, including mixed models, variance component analysis, equivalency studies, nonlinear regression, and Bayesian analysis. Proficiency in statistical software such as JMP, SAS, and/or R. Strong analytical, detail‑oriented, and proactive learning abilities. Excellent communication skills and the ability to collaborate effectively across functions. Preferred Skills and Experience An understanding of disease biology and drug discovery and development is preferred. Salary Range $117,000.00 – $184,200.00 Benefits Includes medical, dental, vision, and other healthcare benefits for employees and families, retirement benefits including a 401(k) plan, paid holidays, vacation, and compassionate and sick leave. EEO Statement As an Equal Employment Opportunity Employer, we prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status. #J-18808-Ljbffr Merck & Co.

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Scientist, Biostatistics, CMC Statistics in Rahway, NJ vacancy
  • $117k - $184.2k

    Job Overview In BARDS (Biostatistics and Research Decision Sciences) within...  ...division, quantitative scientists collaborate with subject matter...  ...development projects in the CMC (Chemistry, Manufacturing &...  ...management, regulatory, statistical programming, data management... 
    Senior
    For contractors
    Local area

    MSD Malaysia

    Rahway, NJ
    3 days ago
  • $117k - $184.2k

     ...Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished...  ...Development division, quantitative scientists, in partnership with other subject matter...  ..., Manufacturing, and Controls (CMC) Statistics area in biologics. Responsibilities... 
    Senior
    Full time
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    Rahway, NJ
    5 days ago
  • Merck & Co. is seeking a skilled Biostatistical Scientist to provide leadership in drug development projects in Rahway, New Jersey. The role requires proficiency in statistical methodologies and tools to support the research and development of medical drugs and vaccines... 
    Senior

    Merck & Co.

    Rahway, NJ
    1 day ago
  • $117k - $184.2k

     ...milestones in global healthcare. In BARDS (Biostatistics and Research Decision Sciences), a...  ...and Development division, quantitative scientists, in partnership with other subject matter...  ...projects in Early Clinical Development Statistics. Ensures that sound scientific... 
    Senior
    Full time
    For contractors
    Local area
    Worldwide
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    MSD

    Rahway, NJ
    8 hours ago
  • $282.2k

     ...Senior Director (Sr. Principal Scientist) The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing...  ...of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects... 
    Senior

    Merck

    Rahway, NJ
    2 days ago
  • $117k - $184.2k

    Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department...  ...Development division, quantitative scientists, in partnership with other subject...  ...and analytical support to statistical programmers and statisticians Education... 
    Senior
    For contractors
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    Rahway, NJ
    1 day ago
  • Associate Principal Scientist (Assoc. Director), Regulatory Affairs - CMC Company: Merck & Co. Location: Rahway, NJ. Job Description: Global Regulatory Affairs & Clinical Safety (GRACS) CMC - Associate Principal Scientist, CMC - Pharm Pre-approval (Respiratory/Inhalation... 

    Clough AMEC.

    Rahway, NJ
    3 days ago
  • $173.2k - $272.6k

     ...individual to join our team as a Principal Scientist. In this role, the successful candidate...  ...lead cross‑functional teams to develop CMC packages for our pipeline assets and...  ...media, CHO cell biology and metabolism, DOE statistics and computational fluid dynamics.... 
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    Rahway, NJ
    1 day ago
  • $173.2k - $272.6k

    Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department...  ...Development division, quantitative scientists, in partnership with other subject...  ...and analytical support to statistical programmers and statisticians. Lead and... 
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours

    Merck & Co.

    Rahway, NJ
    3 days ago
  • $190.8k - $300.3k

    Senior Principal Scientist, Downstream Process DevelopmentSkip to main content*This site uses cookies...  ...presentations* Knowledge of biologics CMC development* Adaptability and agility...  ..., mechanistic and facility modeling; statistical analysis, and computational fluid... 
    Senior
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    MSD Malaysia

    Rahway, NJ
    1 day ago
  •  ...electronic submission process with tools/templates focusing on traceability, QA, data conformance, and data fitness. Collaborate with statistical programming, statistics, regulatory, and other stakeholders. Primary Activities Prepare for PreNDA/PreBLA meetings; develop study... 
    Senior
    Worldwide

    Scorpion Therapeutics

    Rahway, NJ
    1 day ago
  • $117k - $184.2k

    Senior Scientist - Digital Technologies (DDT), DSCS Locations: Rahway, NJ or West Point, PA . We seek a Senior Scientist to build and deploy...  ...experts in automation, data science, modeling, IT, and the CMC community at large. Lead high‑impact projects from concept through... 
    Senior

    Merck & Co.

    Rahway, NJ
    1 day ago
  • $117k - $184.2k

    Job Overview Senior Scientist - DSCS Digital Technologies (DDT)Location: Rahway, NJ or West Point, PA Join a global biopharmaceutical leader...  ...Collaborate across automation, data science, modeling, IT, and CMC disciplines to deliver high‑impact projects. Lead projects from... 
    Senior

    MSD Malaysia

    Rahway, NJ
    1 day ago
  • $282.2k

     ...Job Description The Senior Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research...  ...of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects... 
    Senior
    Full time
    For contractors
    Local area
    Relocation
    Visa sponsorship
    Flexible hours
    Shift work

    Merck & Co.

    Rahway, NJ
    11 days ago
  • Merck & Co. is seeking an Associate Principal Scientist in Regulatory Affairs, based in Rahway, NJ. The role involves developing and implementing CMC regulatory strategies for our pharmaceutical pipeline, focusing on respiratory and inhalation product development. The ideal... 

    Clough AMEC.

    Rahway, NJ
    2 days ago
  • $173.2k - $272.6k

     ...Principal Scientist – Screening & Compound Profiling (Quantitative Biosciences) – Rahway,...  ...Laboratories in Rahway, NJ. This role will provide senior-level expertise at the interface of in...  ...differential equations, and applied statistics as used in pharmacological modeling and... 
    For contractors

    MSD Malaysia

    Rahway, NJ
    4 days ago
  • MSD Malaysia seeks a Distinguished Scientist to lead Quantitative Biosciences research in drug discovery and R&D in Rahway, New Jersey. This critical role involves developing pharmacology strategies and mentoring scientists across various disciplines. The ideal candidate... 
    Senior

    MSD Malaysia

    Rahway, NJ
    3 days ago
  • MSD Malaysia in Rahway, NJ, is seeking a Senior Scientist for Cell Culture Sciences to drive strategy and technical direction for biologics commercialization. This role involves developing robust strategies, providing oversight of cell culture processes, and managing regulatory... 
    Senior

    MSD Malaysia

    Rahway, NJ
    2 days ago
  • MSD Malaysia in Rahway is looking for a professional in Pharmaceutical Sciences to support formulation development of new chemical entities from first-in-human formulations to market definition. The ideal candidate will have a Ph.D. in a relevant discipline and a minimum...
    Senior

    MSD Malaysia

    Rahway, NJ
    1 day ago
  • Merck is seeking a strong candidate for the position of Senior Scientist to support biopharmaceutics assessment for drugs. The role focuses on influencing formulation and delivery strategies while collaborating with interdisciplinary teams. Candidates must have a PhD or... 
    Senior

    Merck

    Rahway, NJ
    3 days ago
  • Merck & Co. in Rahway, New Jersey is seeking an Associate Principal Scientist to develop and optimize cell culture processes for their biologics pipeline. The successful candidate will lead upstream process development efforts and collaborate with cross-functional teams... 
    Senior

    Merck & Co.

    Rahway, NJ
    15 hours ago
  • $117k - $184.2k

    Merck & Co. in Rahway, NJ is seeking a Senior Scientist to join their Pharmaceutical Analytical Sciences group. This role involves tackling analytical development challenges and implementing methods for drug development under GMP conditions. The ideal candidate should... 
    Senior

    Merck & Co.

    Rahway, NJ
    4 days ago
  • Merck & Co. is seeking a skilled professional in Rahway, NJ to support statistical programming for drug development. This role requires expertise in analysis and reporting deliverables, along with a strong background in clinical trials. The ideal candidate will have a BA... 
    Senior

    Merck & Co.

    Rahway, NJ
    15 hours ago
  • $142.4k - $224.1k

    Merck & Co. is seeking an experienced Associate Principal Scientist to support pharmaceutical packaging engineering projects. The ideal candidate will have extensive knowledge of glass components, such as syringes and vials. This hybrid role will involve working closely... 
    Senior

    Merck & Co.

    Rahway, NJ
    15 hours ago
  • $142.4k - $224.1k

    Merck & Co. is seeking an Associate Principal Scientist in Rahway, NJ, to lead design verification strategies for innovative drug-device combination products. You will oversee project leadership, ensuring testing aligns with manufacturing and regulatory standards. The role... 
    Senior

    Merck & Co.

    Rahway, NJ
    2 days ago
  • MSD Malaysia, located in Rahway, NJ, seeks a Senior Scientist to lead the integration of advanced digital capabilities in laboratory environments for accelerated pharmaceutical development. This role entails improving data collection processes, designing innovative solutions... 
    Senior

    MSD Malaysia

    Rahway, NJ
    1 day ago
  • $144.37k - $224.1k

    Associate Principal Scientist, Statistical Programming - Rahway, NJ: Provide high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders Oncology therapeutic area. Responsibilities Gather and interpret user... 
    For contractors

    MSD Malaysia

    Rahway, NJ
    15 hours ago
  • MSD Malaysia is looking for a Principal Scientist in Materials Science to join their team in Rahway, NJ. The role focuses on the physicochemical characterization of pharmaceutical materials and requires strong expertise in physical chemistry and materials science. The ideal... 
    Senior

    MSD Malaysia

    Rahway, NJ
    1 day ago
  • $90.2k - $128.5k

     ...Home ( / Job Search ( / 237799 Senior Chemist II, Makeup Formulation Development Clark, NJ, New Jersey Apply now ( Back Permanent New...  ...environment. We Are Looking For: You are a creative, self-motivated scientist with a passion for face makeup and a strong drive for... 
    Senior
    Permanent employment
    Full time
    Work experience placement
    Summer work
    Work at office
    Work from home
    Flexible hours

    L Oreal USA

    Clark, NJ
    5 hours ago
  • Scorpion Therapeutics is looking for a qualified professional to oversee quality management of submission data for worldwide regulatory applications related to drug and vaccine clinical development projects in Rahway, New Jersey. The ideal candidate will have a background...
    Senior
    Worldwide

    Scorpion Therapeutics

    Rahway, NJ
    1 day ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Scientist, Biostatistics, CMC Statistics. Be the first to apply!