Senior Manager/Associate Director, Statistics, Growth & Emerging Markets and Europe & Canada

Company: Takeda Pharmaceutical
Location: Marion
Posted on: November 24, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:Join us as a Senior Manager or an Associate Director, Statistics, GEM & EUCAN statistics group, in our Cambridge, MA office. The GEM (Growth & Emerging Markets) and EUCAN (Europe & Canada) statistics group is a dedicated, single point of contact within the Takeda statistics department for statistical and related support to diverse post-marketing activities of GEM and EUCAN, including evidence generation.Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data Sciences Institute (DSI) is made up of more than 250 quantitative scientists who harness the insight of data and digital to speed the development of innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.As part of DSI, the Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, understanding of the statistical programming function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence.To attract and retain the very best talent, we in Takeda SQS are open to flexible or remote working for some roles. Such roles will have a connection to a Takeda R&D center.How you will contribute:The Senior Manager/Associate Director is responsible for assisting the Director, Statistics with biostatistics-related activities in support of diverse GEM and EUCAN projects, including analysis and programming. As needed, be available for timely collaboration (meetings, deliverables, etc.) with GEM and EUCAN teams during part of their working hours, which may not be the same as U.S. normal working hours. Assists or leads in providing statistical and related support to GEM and EUCAN, including mainly the following types: analysis and reporting, deliverables review (protocols, SAPs, manuscripts, etc.), statistical content development, calculations, consulting, custom trainings, and statistical evidence generation research. Assists or leads other activities as assigned. Contributes to GEM & EUCAN strategy, and serves as a statistical consultant in post-marketing and communication activities. As assigned, represents Takeda and provides input to his/her supervisor for statistical issues in communications with regulatory authorities and with safety and steering committees.

• Provides statistical and related input to activities pertaining to GEM & EUCAN projects. - Collaborates with teams on planning, design, analysis and reporting; selects appropriate statistical methodologies; provides input into strategies, plans and deliverables.
• Participates in timely collaboration with GEM and EUCAN teams during part of their working hours, which may not be the same as U.S. normal working hours.
• Reviews SAPs, abstracts, manuscripts, study protocols, and other deliverables.
• Performs calculations of study sample size, power, probabilities.
• Consults with teams on study design, protocols, planned publications.
• Performs statistical programming of datasets, tables, listings, and figures.
• Performs statistical analysis, including meta-analysis.
• Provides input to custom trainings.
• Conducts statistical evidence generation research.
• Leads or contributes to departmental process improvement initiatives and development/revision of SOPs.Minimum Requirements/Qualifications:
  • PhD (degree in statistics/biostatistics or in other sciences (requirement of Data Science / Quantitative Science: Biostatistics, Physics, Electrical Engineering, Biomedical Engineering, Computer Science, Applied Mathematics) with -3+ years experience in statistical/quantitative statistical environment
  • MS (degree in statistics/biostatistics or in other sciences (requirement of Data Science / Quantitative Science: Biostatistics, Physics, Electrical Engineering, Biomedical Engineering, Computer Science, Applied Mathematics) with -6+ years experience
    • Experience of clinical study designs, analysis methodology and data interpretation.
    • Experience of pharmaceutical industry, overall drug development process with expertise in the interfaces with the Statistics function.
    • Experience of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
    • Strong background and working knowledge of statistical methodologies that apply to all phases of clinical trials and primarily phase 4, observational (non-interventional) -studies. Must have a working knowledge of SAPs and specifications, mockup tables, figures and data listing shells and appendices.
    • Must have a working knowledge of appropriate relevant regulatory guidance documents (e.g. ICH, FDA and EMA).
    • Proficiency in SAS is strongly required. Proficiency in R is a plus.
    • Experience with clinical trials and statistical issues, to leverage for phase 4 observational-studies, where applicable.
    • Experience with phase 4, observational studies and statistical issues.
    • Ability to help others understand the broader business and organizational context (inspiring and motivating others)
    • Demonstrated ability to aid in delivering excellence by integrating planning efforts across GEM and EUCAN, where applicable, to ensure organizational effectiveness (delivering excellence)
    • Demonstrates a customer focus by partnering with customers (GEM & EUCAN) as a trusted collaborator and serves as an integral part of customer's decision-making process (serving customers)
    • Demonstrated ability to reinforce a culture in which partnering is a norm (global and cross-boundary communication)
    • Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership)
    • Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)What Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • 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 and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.Base Salary Range: $130,000 to $186,000, based on candidate professional experience level. - Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. - - -EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Cedar Rapids , Senior Manager/Associate Director, Statistics, Growth & Emerging Markets and Europe & Canada, Executive , Marion, Iowa