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Associate Director Statistics

Cambridge, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

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  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

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Associate Director Statistics

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Job ID R0022748 Date posted 09/21/2020 Location Cambridge, Massachusetts

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Job Description

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 8+ years experience or PhD degree in Statistics with 5+ years experience.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0022748

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