Associate Director Statistics
Posted on: 30 Apr 2021
Cambridge, MA
Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director in our Cambridge location.
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. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Provide statistical oversight for multiple marketed products, while collaborating with clinical science, drug safety, regulatory, and other R&D functions in the strategic management of marketed products.
Candidate expectations include the following:
Independently manage the statistical aspects of clinical studies including: study protocol design, SAP, management of statistical deliverable, writing of study report.
Provide oversight of statistical work performed by contract clinical research organizations.
Experience leading NDA/SNDA (or similar) submission including product labeling.
Experience interacting with and responding to regulatory agencies (e.g. FDA).
Proficiency with interacting with clinical scientist for data interpretation and product strategy.
A strong understanding of the overall drug development process and flexibility to work on multiple different projects simultaneously.
Good analytical and problem solving skills.
Proficient in statistical programming with SAS.
Knowledge of FDA, EMA and ICH regulations and guidelines.
Masters degree in Statistics with 5+ years experience or PhD degree in Statistics with 2+ years experience.
This job posting excludes CO applicants.
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
Takeda
Deerfield, IL
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Neuroscience and Rare Diseases. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
Takeda is among the top 14 largest and 14th fastest growing pharmaceutical companies in the United States.* We have more than 18,000 employees in the U.S. dedicated to helping patients across several parts of our business. Our U.S. Hub in Massachusetts is the operational center for the U.S. commercial business unit, Global R&D, Global Oncology, Global Vaccines, and biologics manufacturing.
*Based on IMS Health’s National Sales Perspective (NSP), March 2019
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IndustryBiopharmaceuticals
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No. of Employees18,000+
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Website
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Jobs Posted176
