- Genmab (NJ)
- …designated compound/indicationFollow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may ... pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory submissions including BLAs… more
- Merck & Co. (North Wales, PA)
- …Position Description This position is for a principal scientist in biostatistics .-The candidate should have a solid knowledge of statistical methodology, ... Qualifications : Education Minimum Requirement: --Ph.D- (preferred) or MS in Biostatistics or StatisticsRequired Experience and Skills: -With a MS, a minimum… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn BARDS ( Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, ... & Skills Education and Minimum Requirement: PhD or equivalent degree in statistics/ biostatistics or related discipline, or a Master's degree with a minimum of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionIn Biostatistics and Research Decision Sciences (BARDS), a distinguished department within our renowned Research and Development division, ... and professional growth within the team.Education:M.S. or Ph.D. in Statistics, Biostatistics or related fieldRequired Experience and Skills:Minimum of 15 years of… more
- Genmab (NJ)
- …designated compound/indicationFollow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may ... support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionIn BARDS ( Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, ... DayValid Driving License:NoHazardous Material(s):n/aRequired Skills:-Preferred Skills:Algorithms, Algorithms, Applied Mathematics, Biostatistics , Business Process Improvements, Business Strategies, Clinical Development, Clinical… more
- Merck & Co. (North Wales, PA)
- …is expected to work cross-functionally with clinical development, medical affairs, biostatistics , market access, commercial, and country affiliates and may have ... Requirements: 10%Flexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills: Biostatistics , Clinical Development, Communication, Data Management, Epidemiology, Health Economics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …authors, researchers, investigators, GMA Therapy Area leads, RD clinical leads, biostatistics and Joint Publications Team members on publication activities- Lead ... study publication committee discussions, including monthly, quarterly and yearly publication update meetings as neededoManage timelines of publication outputoFacilitate Publication discussionsoLiaise with internal external authors, academic research… more
- Merck & Co. (South San Francisco, CA)
- …clinical study support staff and scientists (including discovery research, biostatistics , drug metabolism, modeling and simulation, regulatory affairs, and global ... clinical trials operations)Provide clinical pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentationsProvide clear, timely communication and interpretation of study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with or without a reasonable accommodation. Education:PhD In statistics or Biostatistics required Experience:Minimum 5 years of relevant experience in the ... pharmaceutical industry and experiences as a safety statistician required. Travel: 10%Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender… more
- Merck & Co. (North Wales, PA)
- …a recognized school of medicine, public health, management, epidemiology, biostatistics , health policy, pharmacy,- economics or related discipline Required ... Experience and Skills: Expertise/experience in the design and implementation of real-world evidenceA track record of scientific presentations and publications.3+ years relevant experience if Masters' degree only Preferred Experience and Skills: Doctoral… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn 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… more
- Merck & Co. (Rahway, NJ)
- …Assay, Assay Development, Bioanalysis, Bioanalytical Analysis, Biopharmaceutics, Biostatistics , Business, Cell-Based Assays, Chromatographic Techniques, Clinical ... Judgment, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Immunoassays, Immunochemistry, Innovation, Laboratory Informatics, Liquid Chromatography (LC), Management Process, Matrix Management, Mentoring Staff, Method Validation {+ 5 more}-Preferred… more
- Merck & Co. (Rahway, NJ)
- …is expected to work cross-functionally with clinical development, medical affairs, biostatistics , market access, commercial and country affiliates. The incumbent may ... supervise external vendors or partners to execute these activities. The incumbent may have direct interactions with health technology assessment (HTA) agencies, reimbursement decision makers, or national immunization technical advisory groups.Responsibilities… more
- Merck & Co. (Boston, MA)
- …background in pharmaceutical sciences, pharmacometrics, mathematics, statistics/ biostatistics , computational biology/chemistry, chemical/biomedical engineering, or a ... related fieldExtensive experience in performing population PK and PK/PD analyses using standard pharmacometric software (eg NONMEM, R, Monolix, etc.)Deep expertise in pharmacometrics with ability to understand how MIDD can drive portfolio and regulatory… more
- Merck & Co. (San Francisco, CA)
- …pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/ biostatistics , computational biology/chemistry, chemical/biomedical engineering, ... or a related field.- Proficiency in performing pharmacometrics analyses such as population PK, PKPD, ER, MBMA, CTS, etc Knowledge of drug development, pharmacokinetics and pharmacology principles required - Preferred Experience: Proficiency in standard… more
- Aequor (Thousand Oaks, CA)
- …offs. Collaborate with cross-functional teams (clinical operations, site management, biostatistics , stats programming, TA) to optimize trial delivery. Deep ... understanding of Risk Based approaches and its impact with Data Management/Site monitoring operationally - consider the role of both Data Management and Site Management, Statistics and Analytics to layer to the model which will deliver studies with an… more
- Eisai, Inc (Nutley, NJ)
- …directors and MSL leadership, Publications, Medical Communications, Clinical Development, Biostatistics , Field HEOR, Patient Advocacy, and other functional leads to ... align training/education activities as well as congress activities. The position serves as a functional lead on cross functional launch planning and other strategic initiatives for Oncology Medical Affairs. The AD will also continually support and update… more
- Merck & Co. (North Wales, PA)
- Job DescriptionIn 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… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data ... quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader… more
