Senior Scientist, Biostatistics, CMC Statistics
$117k - $184.2kMerck & 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.
$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...SeniorFor contractorsLocal area$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...SeniorFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- 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
$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...SeniorFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$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$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...SeniorFor contractorsRelocationVisa sponsorshipFlexible hoursShift work- 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...
$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....RelocationVisa sponsorshipFlexible hoursShift work$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 contractorsLocal areaRelocationVisa sponsorshipFlexible hours$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...SeniorFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...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...SeniorWorldwide
$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$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$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...SeniorFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- 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...
$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 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 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 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
- 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 & 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
$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. 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
$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$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- 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
$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 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
$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...SeniorPermanent employmentFull timeWork experience placementSummer workWork at officeWork from homeFlexible hours- 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...SeniorWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Scientist, Biostatistics, CMC Statistics. Be the first to apply!
- lab scientist Rahway, NJ
- principal scientist Rahway, NJ
- research scientist - biology Rahway, NJ
- senior principal scientist Rahway, NJ
- drug safety scientist Rahway, NJ
- machine learning scientist Rahway, NJ
- cell culture scientist Rahway, NJ
- analytical scientist Rahway, NJ
- scientist immunology Rahway, NJ
- downstream processing scientist Rahway, NJ

