- BD (Becton, Dickinson and Company) (San Diego, CA)
- …aspects-from concept through to commercialization-with a sharp focus on scientific rigor and regulatory compliance. This new role is ideal for someone who thrives in ... product characterization, verification and validation activities, as well as the regulatory landscapes that guide these activities. By working successfully across… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …The role also requires a strong emphasis on viral safety and regulatory compliance. The successful candidate will bring deep technical expertise and leadership ... workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly collaborative… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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 (San Diego, CA)
- …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 (San Francisco, CA)
- …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
- AbbVie (South San Francisco, CA)
- …and regulatory submission. + Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently ... develop protocols and statistical analysis plans. + Represent function/department on project team(s) to provide statistical input to compound/drug development and… more
- AbbVie (South San Francisco, CA)
- …physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians work on ... strategic input to and oversight of the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis … more
- Bristol Myers Squibb (San Diego, CA)
- …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
- US Bank (San Francisco, CA)
- …level management in written and verbal form. Prepares and communicates statistical analysis and findings to audit and regulatory examiners. Reads, understands, ... Financial Crimes (Anti-Money Laundering, Economic Sanctions/OFAC), adhering to OCC 2011-12 Regulatory Guidance and USB's Model Risk Management Policy and Standards.… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- … regulatory submissions, including safety reporting, clinical trial data analysis , and regulatory filings. **Basic Qualifications:** + Advanced scientific ... for promotional and educational materials, clinical trial protocols, and regulatory submissions. + Establish and maintain appropriate scientific interactions with… more