Director Statistics, Vaccines
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Director Statistics, VaccinesApply Now
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 Director, Statistics in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Director working on the Global Statistics team, you will be empowered to innovate, design and build strategies. A typical day will include:
- Leads the development and implementation of operational best practices in the areas of statistical delivery, vendor strategies and oversight. Works in close collaboration with the SQS Head of Programming, the Head of Clinical Data Solutions, and SQS TAU Heads to ensure alignment across relevant stakeholders and SQS processes
- Lead and manage a team of statisticians in Vaccine BU. Support all development projects assigned to his or her team and maximize statistical contributions to clinical, regulatory, and commercial development strategies
- Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses, RWE, including statistical methodology, interpretations, regulatory submissions and follow-up
- Promote efficient innovative designs and optimal development plans
- Contribute to strategies for statistical related technologies, processes, and standards
- Drive the development and lead the implementation, of best practices, statistical guidance, vendor/CRO KPIs/metrics and documentation tools, that can be seamlessly applied regardless of operating/outsourcing model
- Attend relevant Takeda Trial Delivery Operating Model governance meetings and serve as a key leader in our partner relationships
- Ensure operational strategies and plans are in place for ease of management of SQS-centric vendors, e.g. Functional Service Provider (FSP) vendors, including budget and contract management
- Partner with the Head of Statistical Programming to ensure effective tracking and monitoring metrics of vendor quality, cost, and timeliness. Support the escalation and resolution of SQS delivery issues
- Collaborate with the Head of Clinical Data Solutions and Data Standards to ensure our data standards are fit for purpose and effectively communicated and utilized internally and externally
- Support and drive the development and implementation of tools and technologies for SQS delivery tracking and vendor performance metrics
- Vaccine Statistics:
- Ensure adequate statistical support for development projects in the Vaccine statistics group and timely delivery of statistical deliverables
- Oversee aligned statistics resource needs
- Develop and retain statistical talents in the group
- Ensure productive collaborations with other functions and other groups
- Promote innovative designs and efficient analysis methodologies in clinical trials
- Provide statistical advice and consultation to development teams
- Keep the group current on statistical methodologies relating to drug development and regulatory requirements
- Build and maintain a good network with external statistical experts
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
- PhD in Statistics or Biostatistics and 10+ years of pharmaceutical/biotech experiences OR MS in Statistics or Biostatistics and 15+ years of pharmaceutical/biotech experiences
- Excellent technical skills
- Good knowledge of statistical methodologies for aligned TA clinical trials
- Outstanding communication skills
- Strong leadership and influencing skills
- Interact effectively with regulatory authorities
- NDA/BLA filing experience
- Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries.
- Inspires and motivates the group. Takes stand on important issues in productive and respectful way.
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.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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Job ID R0020995