Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Senior Scientific Fellow-Statistics in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.
As a Senior Scientific Fellow-Statistics working on the team, a typical day will include:
The Senior Scientific Fellow is a recognized technical expert and thought-leader who provides broad statistical leadership for all compounds in one large TA with multiple sub-TAs or cross multiple TAs. He/She identifies, develops, and acquires innovative statistical methodologies and ensures that the Statistics and Quantitative Sciences Department is strategically and tactically positioned to meet current and future business needs and regulatory requirements for the company.
- Ensures that technical and scientific standards within Statistics meet current industry trends and regulatory expectations.
- Advises Statistics leadership and project teams on innovative statistical methodology to increase clinical trial efficiency and probability of success for development programs.
- Monitors and influences advances in statistical and clinical trial methodology and serves as internal expert for department with high degree of accountability.
- Provides strategic statistical input for feasibility assessments (i.e. due diligence) including statistical assessment, literature review, clinical development plan development and decision-making.
- Oversees and monitors strategic initiatives aimed at improving decision-making and quality of deliverables.
- Identifies and collaborates with external statistical experts for issues related to design, methodology and results for all compounds.
- In collaboration with multi-disciplinary teams, provides statistical expertise and input to go/no go decisions
- Critically reviews technical and scientific reports from external sources and provides input to the project team as appropriate.
- Conduct original research on relevant statistical topics focusing on current industry trends and regulatory requirements, and coordinates learning/training opportunities within Statistics and for other functional areas.
EDUCATION, EXPERIENCE AND SKILLS:
- PhD in statistics or biostatistics with minimum of 12 years of relevant experience.
- Expert knowledge of statistical design/analysis methodology including latest developments and reporting procedures
- Active in statistical/pharmaceutical professional organizations at regional or national level.
- Proven original research capability with a track record of statistical publications
- Ability to convey statistical argument and concept to influence audience at all levels and with diverse disciplines
- Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and documents.
- Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials
- Experience consulting and/or independently representing Statistics function in submission related-activities and interactions with regulatory agencies, eg, end of Phase II, pre-submission meetings or advisory committee meetings with complex and challenging issues.
- Excellent oral and written communications skills.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.