Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director Statistics, US Medical Office in our Lexington, MA?office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work.
Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do.
Here, you will be a vital contributor to our inspiring, bold mission.
Provides biostatistical leadership for the US Medical Office, bringing statistical and programming expertise into ?phase 3b and phase 4 life-cycle studies, Health Economics and Outcomes Research (HEOR) and publications analyses in support of all USBU products and business needs.
Provides statistical input on all US Medical Office/US Medical Affaires research efforts and is responsible for the timely and accurate preparation of statistical analyses and results presentations in support of USMO research initiatives.
Partners with US medical directors, US HEOR Group and US publications group, and interfaces with US Medical and global cross functional partners to drive resourcing, technologies, processes and standards.
Provides statistical and programming expertise and input into study design for Phase 3b and Phase 4 clinical studies, HEOR activities and analyses for strategic publications for assigned Therapeutic Area (TA).
For assigned TA executes or coordinates with principal statistician or outsourced vendor for all statistical and programing strategies and deliverables for Phase 3b and Phase 4 clinical, and HEOR studies and publication analyses, ensuring appropriate statistical methodologies are used
Drives development and implementation of innovative statistical solutions for assigned studies but uses standard utility tools, processes and standards to maximize efficiency and improve quality.
Forms integrated partnerships with US Medical Directors, US HEOR, US Medical Affairs Clinical Operations, USBU, GOR, Global Medical Affairs, ?Global Data Services and Pharmacovigilance to drive statistical and programming strategies
Provides input for planning and management of external budgets related to statistical and programming needs for all research conducted by the US Medical Office and US Medical Affairs representing TA assigned.
Stays current on trends and best practices in Stats and any TA specific requirements.
?Ensures compliance of function with Takeda SOPs, standards and all applicable regulations
Other duties as assigned.
EDUCATION, EXPERIENCE AND SKILLS:
MS or PhD in Statistics, Epidemiology or related analytical field.
10+ years experience in the pharmaceutical industry and/or academic research supporting real-world data research.
2+ years of line management or cross functional leadership
Experience managing vendors and other strategic partners
Proven track record in identifying and implementing organization-wide initiatives.
Advanced knowledge of observational study designs, statistical analysis methodologies and data interpretation. Ability to conduct research to solve analytical issues related to real-world data research.
Good knowledge of statistical programming languages (including SAS), software, techniques, and processes.?
Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft Office? products).
Active in statistical/statistical programming/epidemiological professional organizations.
Advanced knowledge of FDA and ICH regulations and industry standards applicable to real-world data research.?
Good knowledge of broad drug development process with expertise in cross-functional interfaces.
Understanding of components of the triple aim of pharmaceutical value, i.e., effectiveness, cost and patient perspective
Advanced knowledge of various health insurance claims and other automated healthcare databases.
Access to transportation to attend various meetings held in proximity to the Takeda offices.
Able to fly to various meetings at investigator, vendor or regulatory agency sites.
Some international travel may be required.
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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please
Full time Associated topics: chief marketing officer, demand generation, endowment, government, marketing, newspaper, product market, regulatory, social media, stewardship
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.