- Bristol Myers Squibb (Cambridge, MA)
- …Key Responsibilities + Formulates, develops, implements innovative novel statistical analysis methods and innovative study designs across therapeutic areas + ... to address key business problems. + Communicates effectively with clinical and regulatory partners and external opinion leaders. + Builds the external reputation of… more
- Sanofi Group (Framingham, MA)
- …reports, control strategies, etc. + Provide technical support and data analysis for investigations and deviation resolution. + Work collaboratively with MSAT ... assessments, and process validation activities at CMOs. + Support regulatory filings and inspections for the processes manufactured at...9 years, or Master's degree with 7 years, or PhD with 5 years in industrially relevant biologics development,… more
- Actalent (Cambridge, MA)
- …Senior Biostatistician to contribute your statistical expertise to the design and analysis of clinical trials and clinical development plans. You will closely ... submissions. Responsibilities + Contribute statistical expertise to the design and analysis of clinical trials and clinical development plans. + Collaborate closely… more
- Sanofi Group (Cambridge, MA)
- … analysis , including quality, relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. + Accountable for all ... be supporting our V division with your safety data analysis talents to support safety monitoring teams. **Job Summary**...methodology and standards for safety analyses. **About you:** + PhD /MS in statistics or related discipline with 6 years… more
- Pfizer (Cambridge, MA)
- …+ Drives team process for preparation of governance presentations. **Program Risk Analysis and Management** + Leads the team in the preparation, implementation, ... development committee. **Submissions** + Provides comprehensive project management for regulatory submission activities for initial market authorizations in major… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …upstream process technology transfers to CDMOs, including documentation review, gap analysis , and risk assessment. + Provide expert technical oversight of upstream ... and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. +… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification ... + Lead complex manufacturing investigations and deviations, ensuring thorough root cause analysis and effective CAPA implementation at CDMOs. + Drive strategies for… more
- UNUM (Boston, MA)
- …today! **General Summary:** This position is responsible for providing expert medical analysis of claims files (or underwriting applications) across Unum US product ... services to the Benefits Center. The Medical Consultant adheres to current regulatory , claim process, and internal workflow standards as set forth in the… more
- DuPont (Marlborough, MA)
- …. Coach and mentor junior scientists in project management, data analysis , documentation practices, and professional growth. Communication & Documentation: . Clearly ... control plans, and proactively participate in reactive chemical process hazard analysis (PHA). . Effectively present complex scientific data and project updates… more
- RELX INC (Cambridge, MA)
- …learning algorithms and AI solutions to solve complex business problems. Data Analysis and Modeling: Oversee advanced data analysis , modeling, and machine ... and their practical applications. + Advanced knowledge of statistical analysis , machine learning algorithms, and data manipulation techniques at enterprise… more