- Teva Pharmaceuticals (Parsippany, NJ)
- …with departments such as Regulatory Affairs, Toxicology, CMC/Formulations, Biostatistics , Legal, Marketing, Accounting/Finance, Global Clinical Operations, and CROs ... in the execution of Clinical Development Plans (CDPs) + Capable of analyzing and interpreting clinical results and provide a guidance to prepare high quality reports working with Medical Writing + Working with Medical Writing team, responsible for authoring… more
- Merck (Rahway, NJ)
- …in a quantitative data science field such as statistics, biostatistics , econometrics, data science, biomedical informatics, health informatics, clinical informatics, ... epidemiology, health economics, biometrics, operations research, engineering, computer science, or similar fields with at least 3 years of relevant data science and programming experience. **Required Experience and Skills:** + A minimum of three or more years… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics , Pharmacology, and other departments to strategically manage benefit-risk ... throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (ie, Phase I through commercialization). **Responsibilities** - Depending on the status of development of the compound, lead… more
- Sanofi Group (Morristown, NJ)
- …related to AI in healthcare **3. About you** Advanced degree in biostatistics , statistics, Data Science, Bioinformatics, or a related field Extensive experience in ... clinical operations with insight in data management, and biometrics Understanding of machine learning, natural language processing, and other relevant AI technologies Strong understanding of clinical development processes and regulatory requirements 10+ years… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …+ Working knowledge of associated disciplines, including immunology, biostatistics , clinical pharmacology, formulation science, data management, and medical ... writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives,… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …+ Working knowledge of associated disciplines, including immunology, biostatistics , clinical pharmacology, formulation science, data management, and medical ... writing. + Experience with the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage. Education Requirements: + Required: Clinician (MD, or DO) preferably a geneticist, metabolic… more
- Taiho Oncology (Princeton, NJ)
- …team members (Medical monitor, Project Manager, Clinical Operations, Data Management, Biostatistics , PV, PK, Biomarkers and Medical Writing etc.), to deliver high ... quality clinical trial results. + Use scientific expertise to support the creation of relevant high-quality clinical documents such as study protocols and clinical study reports (CSRs), investigator brochures, DSUR, NDA/MAA registration documents and… more
- Sanofi Group (Morristown, NJ)
- …internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics , drug discovery, drug safety, marketing. + Advance the CDP ... through internal management review. + Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. + Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other… more
- Sanofi Group (Bridgewater, NJ)
- …Your skills could be critical in helping our teams accelerate progress. Join our Biostatistics team as a Safety Expert Statistician and you'll be supporting our V ... division with your safety data analysis talents to support safety monitoring teams. **Job Summary** Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and… more
- Merck (Rahway, NJ)
- **Job Description** In BARDS ( Biostatistics and Research Decision Sciences), a distinguished department within our 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… more