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Scientific Fellow (Associated Director, Statistics in Oncology)

Boston, 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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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • 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.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • 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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Scientific Fellow (Associated Director, Statistics in Oncology)

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Job ID R0023056 Date posted 09/21/2020 Location Boston, Massachusetts

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Job Description

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 Principal / Scientific Fellow in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Principal / Scientific Fellow working on the statistical quantitative  team, you will be empowered the R&D  statistical team  and a typical day will include: 

OBJECTIVE: 

  • Provide statistical leadership in the design, analysis, and interpretation of clinical studies at a compound level and/or therapeutic area (TA) level, promoting innovative design and analysis methodology.
  • Provide strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions and interactions.
  • Independently represent Statistics function in interactions with regulatory authorities and statistical working groups.
  • Monitor and implement advances in statistical and clinical trial methodology for assigned compounds, and promote use of innovative methodologies across TAs.

ACCOUNTABILITIES: 

  • Independently represent the statistics function on global therapeutic areas in support of clinical studies and compound and/or TA-level programs.
  • Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions across therapeutic areas, including timelines.
  • Promote innovative clinical trial designs and efficient analysis methodologies
  • Provide statistical leadership in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables within and across TAs as appropriate.
  • Oversee standards of definition and implementation of therapeutic area level database (including derived database), analysis and reporting standards.  Collaborate with Data Management, Programming, Safety Statistics, Clinical and PV to provide suggestions for achieving high quality databases and specifications.
  • Oversee compound and/or TA-level analysis and reporting activities.
  • Identify and interact with external statistical experts for issues related to design, methodology and results as the primary contact and spokesperson.
  • Increase efficiency of the Statistics function through development of standard and/or innovative analysis methodology, data presentations, global integratability and sharing of best practices.
  • Leverage scientific expertise for strategic statistical leadership by providing recommendations and statistical consultations to management
  • Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analyses techniques, and lead implementation of innovative approaches within and/or across TAs as appropriate.

EDUCATION, EXPERIENCE AND SKILLS: 

  • PhD in statistics or biostatistics with a minimum of 8 years of relevant experience Expert knowledge of statistical design/analysis methodology including latest developments and reporting proceduresExtensive statistical and operational knowledge in at least one therapeutic area
  • Demonstrated successful track record in working with various development teams
  • Active in statistical/pharmaceutical professional organizations at regional or national level.
  • 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 interactions with regulatory agencies
  • Excellent oral and written communications skills.
  • Expertis in statistical programming, modeling and simulations

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0023056

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