Description

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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 Director of CMC Statistics in our Cambridge office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director of Statistics, you will be empowered to provide statistical leadership in the design, analysis, and interpretation of CMC study data throughout Pharmaceutical Sciences, promoting innovative design and analysis methodology.

OBJECTIVE:

  • Drive statistical support for Takeda CMC campaigns, to support design and analysis for analytical development and formulation development for synthetic molecules, biologics, cell therapies, and other drug modalities.

  • Drive collaborations with Global Manufacturing, Regulatory Affairs, and Global Quality to harmonize methods and contribute to the implementation of CMC strategies to enable data driven decision making.

  • Serve as an expert, mentor, and manager in Quantitative Sciences group within Statistical and Quantitative Sciences line implementing statistical CMC development strategies using statistics and cross-disciplinary integrative data analytics.

ACCOUNTABILITIES:

  • Lead implementation of SQS strategies, goals, and priorities. Oversee and ensure achievement of all deliverables and milestones for multiple programs.

  • Align efforts and resource allocation with PharmSci and TA strategies, portfolio priorities, and partner lines work.

  • Strategize and prioritize opportunities for Quantitative Sciences group in statistics, advanced analytics and modeling to maximize impact on the organization.

  • Manage, mentor and grow team of statisticians and contractors to deliver rigorous and robust statistical methods to PharmSci programs.

  • Promote statistical innovation and collaborations across a network of statisticians and data scientists to advance CMC research.

  • Develop and manage relationships with the external research community. Serve as the scientific point person at the meetings with KOLs, conferences, industry events

  • Provide statistical leadership in the development and review of the statistical analysis plans and regulatory submission documents, and ensuring rapid, accurate, statistically valid responses to regulatory questions.

  • Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions across TAs, including timelines.

  • 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, 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 PharmSci as appropriate.

EDUCATION, EXPERIENCE AND SKILLS:

  • PhD in Statistics, Biostatistics, Applied Mathematics, Physics, Engineering, or related quantitative filed with 10+ years of experience

  • Knowledge of pharmaceutical drug development and ICH/USP/FDA/EMA guidelines with a relevant track record of R&D hands-on work and leadership. Experience in various CMC stages of drug development.

  • Expertise and track record of implementation of advanced statistical modeling.

  • Expertise in design and analysis of assay validation/transfer/bridging, comparability, stability/shelf life, quality by design, and specification setting.

  • Experience with Bayesian methods, ML/AI, and other advanced statistical methods with applications to CMC problems.

  • Pragmatic leader with a focus on driving the teams using fit-for-purpose philosophy and a track record of creativity and innovation.

  • Track record of integrating statistical best practices into CMC research to improve reproducibility, reliability, and speed throughout the PharmSci processes.

  • Excellent communication and presentation skills. Ability to translate/explain complex statistical concepts to non-experts; ability to speak across disciplines of Quantitative Sciences umbrella: statistics, engineering, applied mathematics, computational biology, and others.

  • Expertise in statistical programming, modeling and simulations

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Empowering Our People to Shine

Learn more at takedajobs.com .

No Phone Calls or Recruiters Please.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Cambridge, MA

U.S. Base Salary Range:

$169,400.00 – $266,200.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time