- Lilly (Branchburg, NJ)
- …processes, and training. **Basic Qualifications** + Master's degree in Statistics, Biostatistics or MSPH with concentration in Statistics or Biostatistics . ... **Additional Skills/Preferences** + Proficiency in statistical programming languages/software such as SAS, R, Spotfire, etc. + Interpersonal/teamwork skills for effective interactions + Technical growth and application with solid understanding of statistics… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality ... on monitoring plan (eg data fields to be SDV'd) and to Biostatistics on Statistical Analysis Plan (SAP). + **Study Execution:** Reviews patient demographics,… more
- Bristol Myers Squibb (Princeton, NJ)
- …contact for stakeholders including data management, reporting and analytics, and biostatistics . Responsible for planning, connecting to the different data sources, ... designing and developing mappings, scheduling those mappings within the Clinical Data Warehouse, monitoring and maintaining the ETL process within the Clinical Data warehouse. **This position is required onsite in Princeton, New Jersey** **Position… more
- Merck (Rahway, NJ)
- …is expected to work cross-functionally with clinical development, medical affairs, biostatistics , market access, commercial and country affiliates and may have ... direct interactions with health technology assessment (HTA) agencies, reimbursement decision makers and national immunization technical advisory groups. **Responsibilities** **and Primary Activities** + Depending on role, leads or participates in value… more
- Merck (Rahway, NJ)
- …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
- Sumitomo Pharma (Trenton, NJ)
- …of clinical data (safety and efficacy) and a working knowledge of biostatistics , GCP, and regulatory requirements for clinical studies. + Experience with interacting ... with medical monitors, development operations (clinical operations, data management, program management, regulatory affairs, medical writing) and clinical investigators. + Patient profile and data listing review experience. + Up to date in new clinical trial… 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
- Sumitomo Pharma (Trenton, NJ)
- …Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties and Responsibilities** + Work ... collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety. + Assist in signal detection activities including data assembly, signal validation, and signal evaluation. + Perform… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …of 3 years of relevant MW experience including working knowledge of biostatistics . + Solid understanding of the clinical research process and regulations/guidelines ... + Clinical document reading, writing, and editing experience + Strong organizational, interpersonal and communication skills + Solid understanding of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems + Ability to manage multiple… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …are crucial for this role. Advanced knowledge of Data Management, Biostatistics , Clinical Operations, Pharmacovigilance, handling and processing of raw data and ... external data, CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working in fast-paced environment, continuous improvement, project management, change management, and risk… more
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