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Senior Statistician

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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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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Senior Statistician

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Job ID R0016685 Date posted 05/19/2020 Location Cambridge, Massachusetts

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Job Description

Objective

  • The purpose of this position is to provide compound level / development phase statistical expertise and leadership by:
  • Independently designing, analyzing and interpreting clinical studies at a compound level for early phase or less complex programs.
  • Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions.
  • Improving and using standards to maximize global data integratability, interpretability and compound level efficiency
  • Leveraging internal and external resources to achieve quality, timely and cost-effective compound level and submission deliverables.
  • Independently representing Statistics function in interactions with regulatory authorities

Accountabilities

  • Independently represent statistics function on global teams in support of clinical studies and compound level programs.
  • Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions. Negotiate timelines (statistical) at compound level.
  • Plays a leadership role 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.
  • Oversee definition and implementation of compound-level database (including derived database), analysis and reporting standards.  Improve or use existing standards to ensure maximization of global integratibility and interpretability of data and enhance efficiency at compound level.  Coordinate with Data Management, Programming, Clinical and PV to target high quality databases and specifications at compound level.
  • Plan and direct compound level analysis and reporting activities (eg, tables, listings, graphs) including work of other statisticians and programmers.
  • Identify compound level vendor requirements and participate in the evaluation/selection of vendors. Provide compound level analytical 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.
  • Identify and interact with external statistical experts for issues related to study design, methodology and results.
  • Anticipate and communicate internal and external resource and quality issues that may impact deliverables or timelines of the compound level program.  Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
  • Lead the implementation of department standards and process improvements.
  • Lead evaluation and implementation of alternative analysis methodology and data presentation techniques.
  • Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, and implement innovative approaches at a compound level.

Education, Experience & Skills

  • PhD in statistics or biostatistics with at least 3 years of relevant experience or MS in statistics or biostatistics with at least 6 years of relevant experience..
  • Experience with advanced study design or at least one NDA/CTDs or other global regulatory submissions.
  • Advanced knowledge of clinical study designs, common analysis methods, descriptive and inferential statistics.
  • Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents.
  • Extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
  • Good knowledge of statistical programming languages (including SAS), software, techniques, and processes. Working knowledge of UNIX operating systems, and common software products and technologies used in conjunction with SAS (e.g., Microsoft OfficeÒ products).
  • Excellent oral and written communications skills.
  • Strong project management skills.
  • Strong 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.

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

Locations

USA - Boston - Home

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0016685

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