20 days ago on roche.com

Principal Scientist, Real World Data

Roche AG

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Principal Scientist, Real World Data

Principal Scientist, Real World Data

Switzerland, Basel-Town, Basel

The Principal RWD Scientist is responsible for providing RWD expertise, strategic input and leadership to Product Development, Global and Local Medical Affairs, Global Pricing and Market Access and Mature Products.The Senior RWD Scientist is accountable for the scientific rigor of the RWD applications across the lifecycle of the programs. The Principal RWD Scientist typically represents RWD-S on global development teams and global medical affairs teams, partnering with scientists in clinical, safety, biostatistics, regulatory, medical affairs, payer strategy, and MORSE. The Principal RWD Scientist accountabilities typically extend to leading the RWD-S Disease Area Team.

Role Responsibilities:

  • A member of global cross-functional teams and sub-teams (e.g. Global Development Team, Safety).
  • Typically the leader of one or more RWD-S Disease Area Teams and leads RWD strategy for an indication across multiple programs
  • Provide strategic input and RWD-S expertise into the CDP, TPP, AMP, and ABP
  • Understands strategy and needs in development, medical affairs and patient access and provides RWD solutions to address evidence gaps
  • Responsible for the scientific rigor of the RWD studies, regulatory submissions and HTA submissions within the disease areas
  • Oversees the deliverables from RWD CROs
  • May serve as the RWD Scientist on the cross-functional study team for RWD studies, with the incumbent responsibilities and accountabilities.

Functional Area:

  • Engages in research and development of RWD science methodology in alignment with current project needs and future trends of RWD-S
  • Leads RWD-S and cross-functional initiatives
  • Mentors RWD Scientists and Analysts.
  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
    • MSc or PhD in Epidemiology, Outcomes Research, Statistics, Biostatistics, Mathematics or similar areas of academic discipline
    • Excellent understanding of private and public real-world data sources
    • Excellent knowledge and experience in design, implementation and reporting of real-world data studies in the pharmaceutical industry
    • Excellent knowledge of international regulatory and ICH GCP guidelines.
    • Largely autonomous to accomplish responsibilities
    • Excellent communication and collaborations skills (including interpersonal skills to contribute effectively in cross-functional team settings, ability to influence others without authority, ability to build strong collaborative relationships with scientific and non-scientific partners)
    • Excellent project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors, and external vendors)
    • Excellent strategic ability (including problem-solving and critical thinking skills, ability to drive drug development and patient access strategies, agility that extends beyond RWD expertise)
  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Development
    • Subfunction Biometrics / Biostatistics
    • Schedule Full-time
    • Job level Individual Contributor
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Posted since 2017/11/23
    • Posted until 2017/12/23
    • Job-ID 3424527229
  • Get in touch
    Mathieu Vetter +41 61 688 41 00

    Work location: Basel