- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction from group head and provide statistical scientific leadership for clinical trial safety data . Lead the statistical support for safety signal ... leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring...for ongoing studies and compound level pooled clinical trial data of project(s). Act as statistical expert consultant within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …management/oversight. PV experience/knowledge preferred Contracting process for PV vendors (eg Safety Data Exchange Agreement) Excellent interpersonal skills and ... regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The… more
- Eisai, Inc (Nutley, NJ)
- …related technical and end user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. ... manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but is not limited… more
- Twist BioScience (South San Francisco, CA)
- …the efficient and compliant management of regulatory documentation, with a primary focus on Safety Data Sheets (SDS), product labeling, and SOP's. This role is ... and product specifications.What You'll Be Doing Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global… more
- Merck & Co. (Rahway, NJ)
- … data preprocessing, filtering, and manipulationProgramming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic data (raw ... with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the data into analysis/modeling datasets, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …risk factors with and for other technical departments (eg, Clinical, Medical, Safety , Data Management, Statistics). This position requires skills in working ... different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface… more
- Merck & Co. (Rahway, NJ)
- …in CDISC SDTM and ADaM standards.Must possess programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic data (raw ... oncology.Gather and interpret user requirements for programming requests, retrieve required data , transform data into analysis/modeling datasets, and develop… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… more
- Insmed Incorporated (San Diego, CA)
- …external audit observations and development of adverse trends) to ensure patient safety and data integrity.Supports strategic direction with cross functional ... working groups to identify and mitigate GCP quality and compliance issues.Supports the evaluation and acceptability of vendors for potential use and provides direction, guidance and strategy for company Quality Assurance.Full understanding of and practical… more
- Genmab (NJ)
- …at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker ... authorities or ethics committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs sponsor oversight… more
- Formation Bio (New York, NY)
- …development of sophisticated models to predict clinical outcomes-determining drug efficacy, safety profiles, and optimal indications-to create a data -driven ... patients faster and more efficiently.About the PositionAs AD/Director of Data Science - Platform at Formation Bio, you will...will lead one of two critical arms of our Data Science function, focusing on building predictive capabilities that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... (PV) oversight. This role fulfills the PV Oversight for NNI Patient Safety processes and as providing SME-level input from the affiliate perspective when… more
- Novo Nordisk Inc. (Durham, NC)
- …& Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. Identify and share better practices, to include ... increasing awareness of data management standards & validation to create improvements in...tools when relevant Lead in the following of all safety & environmental requirements in the performance of duties… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... data innovation, maintaining our facilities and assuring the integrity...role reports directly to the Vice President of Enterprise Data & Advanced Analytics (ED&AA) and serves as a… more
- Merck & Co. (Rahway, NJ)
- …data completeness and integrity, and ultimately interpreting and contextualizing aggregate data to assess safety and efficacyWork closely with a ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports,… more
- Genmab (NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab… more
- Merck & Co. (Rahway, NJ)
- …responsible for-ensuring reliability and efficiency of site operations through data -analytics.-This role will-assess current state analytics and collaborate with ... strategy for Rahway-and support the-regional portfolio.This role will develop a plan to-utilize- data visualization, data analysis, data monitoring and … more
- Genmab (NJ)
- …trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data packages ... discussionsActs as a role modelEnsures consistency of statistical methods and data handling across trialsEnsures all compound/indication related work and information… more
- Aequor (Pearl River, LA)
- …that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design ... with a passion for using high-dimensional single cell immune profiling data in conjunction with innovative computational approaches and systems immunology knowledge… more
