- Pfizer (Cambridge, MA)
- …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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …all **pharmacometrics** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions. You will conduct analysis , execution and reporting of ... **population PK, PK/PD and modeling and simulation** . + **Provide pharmacometrics analysis ** and participates in activities related to analysis and reporting… more
- Burns & McDonnell (Newton, MA)
- …by regulatory agencies. + Develops and conducts detailed financial analysis using a variety of computer-based software. + Develops technical reports and ... consulting services to help clients make decisions backed by business and engineering analysis . This role will contribute to the execution of technical studies and… more
- Merck (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... driving pipeline impact: population pharmacokinetics (PK) and pharmacodynamics (PD) analysis , model-based meta- analysis (MBMA), clinical trial simulations (CTS),… more
- Bristol Myers Squibb (Cambridge, MA)
- …TLs to address nonclinical translational questions + Participates in post-hoc biomarker analysis and publication efforts + Supports regulatory submissions and ... activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. Translational Development drives… more
- Sanofi Group (Cambridge, MA)
- …analyses + In-depth knowledge of clinical trial design, biostatistics, and data analysis . + Proficient in regulatory requirements and guidelines for clinical ... exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first… more
- Harvard University (Cambridge, MA)
- …submit proposals to fund the research; secure and maintain IRB and regulatory approvals; conduct analysis , publish findings, and disseminate research findings ... task-sharing for scale-up of proven interventions. We welcome applications from recent PhD graduates who are interested in these or related fields, particularly… more
- Burns & McDonnell (Newton, MA)
- …risk assessments that evaluate impacts associated with rules implemented by regulatory agencies. + Reviews financial analysis completed by consultants ... help clients make decisions backed by business and engineering analysis . The senior consultant will directly engage with clients...engineering or business and 6 years of experience or PhD in Engineering or Business and 5 years of… more
- Takeda Pharmaceuticals (Boston, MA)
- …data science expertise by: + Providing statistical support in the design, analysis , and interpretation of preclinical studies to enable quantitative decision making ... from statistics, machine learning, and AI) and fit-for-purpose statistical analysis in support of Discovery efforts from projects start...+ Education in a relevant field, for example a) PhD in a field such as Biostatistics, Applied Mathematics,… more
- Takeda Pharmaceuticals (Boston, MA)
- …and drug combination strategies. + Oversee data integration and network/pathway analysis to understand mechanisms of action, ensuring robust and insightful ... teams to influence experimental design, assay development, data generation, and analysis , ensuring alignment with strategic objectives and scientific rigor. + Lead… more