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Sr. Principal Statistician/Scientific Fellow

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

  • Innovation

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

  • Values-Led

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

  • People-First

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

  • Empowerment

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

  • Collaboration

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

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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Sr. Principal Statistician/Scientific Fellow

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Job ID R0005861 Date posted 01/14/2019 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: 

The purpose of this position is to provide study level statistical expertise by:

  • Participating in designing and independently analyzing and interpreting data from clinical studies.
  • Using standards to maximize global data integratability and interpretability.
  • Leveraging internal and external resources to achieve quality, timely and cost-effective study deliverables.

ACCOUNTABILITIES: 

  • Represent the statistics function in support of clinical studies, generally supporting multiple studies at a time.
  • Provide statistical input to feasibility assessments, development and submission plans, and in support of regulatory submissions.
  • Provide statistical support with minimal supervision 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.
  • Implement project level database (including derived database), analysis and reporting standards. Provide suggestions to achieve high quality databases and specifications by working with Data Management and Programming at project level.
  • Plan and direct study-level analysis and reporting activities (eg, tables, listings, graphs) including review of work by programmers.
  • Identify study-level vendor requirements and participate in the evaluation/selection of analytical vendors. Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs. Review and approve key statistical vendor deliverables.
  • Anticipate and communicate study level resource and quality issues that may impact deliverables or timelines.  Propose and implement solutions. Escalate issues to management as appropriate.
  • Consider and evaluate alternative analysis methodology and data presentation techniques. 
  • Support development and implementation of departmental standards and process improvements.

EDUCATION, EXPERIENCE AND SKILLS: 

  • PhD in statistics or biostatistics or equivalent with minimum of 8 years of relevant experience or MS in statistics or biostatistics or equivalent with minimum of 12 years of relevant experience.
  • Expert knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics, summarization of data and presentation practices.
  • Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
  • Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
  • Advanced knowledge of statistical programming languages (including SAS), software. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft OfficeÒ products).
  • Project management skills.
  • Excellent oral and written communications skills.
  • Good collaborative skills and ability to work with a cross-functional team.

TRAVEL REQUIREMENTS:

  • 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.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0005861

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