- Merck (North Wales, PA)
- …, Exercises Judgment, Goal-Oriented, Legislative Testimony, Management Process, Regulatory Affairs Management, Regulatory Communications, Regulatory ... **Job Description** At the heart of innovation, our Regulatory Affairs team plays a vital role in...robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the leading… more
- Merck (North Wales, PA)
- …design, analysis , and interpretation posed by the clinical monitors, regulatory agencies, or investigators. 10. Responsible for ensuring the accuracy of ... experience. **Preferred Experience and Skills:** Broader scientific leadership in design and analysis of clinical trials; Experience with regulatory filing for… more
- System One (Pittsburgh, PA)
- …Biostatistician in Clinical Research will play a critical role in the design, analysis , and interpretation of clinical trial data to ensure the validity and accuracy ... clinical data and will be responsible for contributing to study protocols, statistical analysis plans, and final study reports. If you are intrigued and would like… more
- PNC (Pittsburgh, PA)
- …that PNC Bank's high impact models comply will all applicable internal and regulatory rules and policies. You would additionally: * Serve as subject matter expert ... models are conceptually sound and compliant with the pertinent internal and regulatory policies. Document and communicate results and findings in Audit workpapers… more
- Merck (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs. The AVP provides leadership and direction through senior-level and… more
- Merck (North Wales, PA)
- …analysis requirements, internal standard operating procedures, and external regulatory requirements. + Evaluates appropriateness of available software for planned ... design, analysis , and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators. + Is responsible for planning and ensuring the… more
- Pfizer (Collegeville, PA)
- …in designing clinical trials, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, ... manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. Successful… more
- Sumitomo Pharma (Harrisburg, PA)
- …with the clinical team on the statistical design of the studies, and the analysis and data presentations for the studies. **Job Duties and Responsibilities** + Serve ... statistical design, authoring statistical sections of study protocols and Statistical Analysis Plans (SAPs), and supporting trial design, including sample size… more
- Merck (West Point, PA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta- analysis (MBMA), clinical trial simulations (CTS) and disease progression… more
- Pfizer (Collegeville, PA)
- …result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives and ... + Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, … more