GI Statistics - Sr Manager

Key Skills

Data Analytics, Statistics, Statistical modeling, Bioinformatics

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, Statistics, GI in our Cambridge, MA 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, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

• Provide leadership at a compound level on clinical, regulatory, and commercial development strategies
• Promote efficient innovative methodologies and optimal development plan
• Contribute to strategies for statistics related technologies, processes, and standards

POSITION 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.
• 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.
• 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, BEHAVIORAL COMPETENCIES AND SKILLS:

• PhD in statistics or biostatistics with a minimum of 6 years of relevant experience Expert knowledge of statistical design/analysis methodology including latest developments and reporting procedures
• Strong collaborative skills and ability to work with a cross-functional team
• Advanced knowledge of clinical study designs, analysis methodology and data interpretation.
• Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function.
• Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
• Excellent oral and written communications skills.
• Expertise in statistical programming, modeling and simulations

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

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.