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Sr Principal/Scientific Fellow-Statistics

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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Sr Principal/Scientific Fellow-Statistics

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Job ID R0016130 Date posted 01/20/2020 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 Scientific Fellow, Statistics in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Scientific Fellow, Statistics, you will be empowered to 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

OBJECTIVES: 

  • Drives statistical aspects of biomarker development for Takeda R&D assets for Oncology TA covering design and analysis from pre-clinical to early clinical studies.
  • Leads collaborations with preclinical, biomarker, translational and clinical scientists to enable data driven decision making.
  • Oversees exploratory statistics activities for one major clinical program or multiple clinical programs to ensure timely and accurate delivery of biomarker analysis plans, publications, reports and regulatory submissions.
  • Independently provides strategic and expert statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study analyses including statistical methodology, interpretations, regulatory submissions and follow up.
  • Establishes and drives Oncology programs functional strategy for resourcing, processes and standards to maximize efficiency and global data integratability.
  • Participates in functional and cross functional initiatives including process and quality improvements.

ACCOUNTABILITIES: 

  • Serve as global statistical lead for biomarker development in Oncolgy TA.
  • Play a leadership role in development and completion of major statistics deliverables and milestones in collaboration with other functions.
  • Drive/participate in development and implementation of global systems, processes and standards to maximize quality and efficiency.
  • Leverage standardized analysis methods and reporting standards to maximize global data integratability; identifies best practice for utilization across programs. 
  • Provide statistical leadership and support for internal decision making, regulatory meetings, submissions and follow up.
  • Provide or identify internal and external statistical expertise and capacity to support development activities.
  • Collaborate/lead in the development of compound/program-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality.
  • Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timeline at the program level. 
  • Provide input for planning and management of external budgets related to statistical deliverables.
  • Participate/Leads in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practice and its applicability in Takeda.

EDUCATION, EXPERIENCE AND SKILLS:

  • PhD in statistics or biostatistics with at least 8 years of relevant industry experience
  • Demonstrated experience in biomarker discovery and development for Oncology TA.
  • Expert knowledge of statistical approaches for assay development and validation, analysis of high-dimensional data utilizing Omics technologies, flow cytometry, multiplexed imaging data
  • Expert knowledge across broad the areas of statistical methodologies inlcuding subgroup analysis, longitudinal data analysis, predictive modeling, machine learing, Bayesian modeling
  • Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
  • Strong statistical programming skills
  • Excellent oral and written communications skills.
  • Strong inter-personal and people management skills.
  • Strong project management skills.
  • Strong collaborative skills and ability to work with a cross-functional team.
  • Ability to influence others, without direct hierarchical authority, and affect change across organizational boundaries. 

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

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0016130

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