- Pfizer (Pearl River, NY)
- …the way in healthcare and make a lasting impact on society. **What You Will Achieve** As a Clinical Study Group Lead , you will be an operational and ... 5 submission subteams and endgame inspection readiness. In the Clinical Study Group Lead... studies + Accountable to deliver excellence in clinical study team leadership for a portfolio… more
- Sanofi Group (Morristown, NJ)
- …datasets, medical imaging data, continuous data from wearable devices) collected from clinical studies for both formal reporting and exploratory analyses ... progress. The Statistical Biomarker Leader is involved in the clinical development process from early on to lead...concepts and techniques in various biomarker data collected in clinical studies + General knowledge of pharmaceutical… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …(ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies . + Proven ability and experience to effectively execute ... Operations leader for a Director position within our Oncology Group . Clinical Operations is responsible for the...to support a fluid 'One Ops' workforce. You will lead and/or effectively engage in Clinical Operations,… more
- Sanofi Group (Morristown, NJ)
- …key external stakeholders. + Ability to understand and effectively communicate vaccine clinical studies , both interventional and observational + Knowledge of ... clinical trials (ie, Ph 4 post-marketing and observational studies ) for new products that may join franchise portfolio...and ESC applications + Liaise with the investigators of study applications. + Present studies to the… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …the preparation/review of related key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The ... the Clinical Development plan + Works with Clinical Supplies Group to ensure clinical...and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant … more
- Sanofi Group (Morristown, NJ)
- …relevant statistical matters: + Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the ... development. As Associate Statistical Project Leader, you will lead several oncology early phase projects or late phase...into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to… more
- Sanofi Group (Morristown, NJ)
- …and Finances to facilitate financial exercises throughout the year, for both tactics and Clinical Studies + Study Prioritization process: + CSS SRC approval ... individual will work closely with his/her respective Medical Program Lead (MPL) and TA Global Medical Team (GMT), both...study data milestones and budget specific to all studies defined in the approved iEGP + Compliance reporting… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …such as team capability development. **EXAMPLE RESPONSIBILITIES:** + Acts as biostatistics lead on clinical studies or other non-molecule projects. ... providing statistical consultation on clinical development plans, clinical trial design and clinical study... endpoints and authors statistical analysis plans. Typically assigned clinical studies or other projects of increasing… more
- Sanofi Group (Morristown, NJ)
- …a cross-functional team. + Ability to understand and effectively communicate vaccine clinical studies , both interventional and observational + Ability to analyze ... of company-sponsored clinical trials (ie, Ph 4 post-marketing and observational studies ) for new products that may join franchise portfolio in accordance with… more
- Sanofi Group (Morristown, NJ)
- …scientific leadership for responsible projects. Accountable for statistical aspects of clinical development plans, studies and submissions activities (when ... As a Statistical Project Leader in Biostatistics, you will Lead one or more indications/projects in an Oncology Development at Sanofi, under minimum supervision of… more
- Pfizer (Pearl River, NY)
- …cellular (B-cell and T-cell) immune response to vaccine candidates in preclinical and clinical studies . + Maintain suspension and adherent cell lines by regular ... in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities… more
- Pfizer (Pearl River, NY)
- …in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities ... Pfizer's Vaccine Research and Development (VRD) organization - Analytical Development group . The candidate assists with development of robust analytical assays in… more
- Pfizer (Pearl River, NY)
- …in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities ... position within the Vaccine Research and Development - Analytical Development group . The candidate contributes to the development of robust analytical assays… more