Senior Manager, Safety & Benefit-Risk Statistics

Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: September 15, 2023

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 and . 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 Takeda as a -Senior Manager, Safety & Benefit-Risk Statistics, -where you will independently represent the Data Science function on projects leading data strategies related to diseases, assets, or other areas of interest in Takeda's ecosystem. You will also lead project delivery directly related to global project teams or other functions.As part of the -Data Sciences Institute (DSI), you will report to Senior Director/Director, Statistics. Partner with colleagues from many functions that span R&D (e.g., pharmacology, chemistry, imaging, translational sciences, computational biology, experimental medicine) to Commercial (patient services, sales, marketing, medical information).Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discovering and delivering 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 for 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 is team-oriented, collaborative, understanding of the statistical programming function, exceptional leaders, and innovators. SQS aspires to bring safe and effective medications to 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 at 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:

• Drive the safety, benefit-risk, and patient-reported outcome deliverables for an asset.
• Work independently and prioritize delivery for projects and with vendors.
• Drive and influence project teams towards seamless delivery while allowing and making decisions.
• Contribute to asset-level strategies to find and address delivery risks.
• Have an internal and external presence on delivery risks and enable risk mitigation actions.
• Can implement process and best practice changes through delivery risks.
• Play a leadership role in the development and review of data science projects and their respective strategies, spanning spontaneous data exploration in individual data sources to designed and planned studies requiring the synthesis of many data archetypes.
• Perform beginning-to-end data analyses, from data strategy to objective formulation, to data exploration and insights, to hypotheses formulation, experimental design, writing analysis plans, data cleaning and curation, executing analysis, to interpretation and preparing reports with documentation.
• Develop and support optimal data handling and data provenance practices utilizing reproducible, interpretable data research approaches.
• Strengthen Takeda's advanced analytics toolkit by identifying and applying emerging innovative techniques, as well as by advancing the state of the art and developing novel analysis tools as needed.
• Collaborate within a matrix environment with business leaders and scientists to identify and develop appropriate goals for data science work (for example identifying sensitive and endpoints for segmenting patient population, tracking disease progression, quantifying quality of life).
• Provide expertise in concepts related to data acquisition and ingestion working with Data Architecture and IT. Understand the respective system's security and provide support for data transparency, disclosure, and governance.
• Work closely with Takeda statisticians and other quantitative experts to ensure statistical issues in data analysis are addressed as needed.
• Anticipate and communicate internal and external resource and quality issues that may impact the deliverables or timelines of the program. Propose and implement solutions. Escalate issues to management as appropriate in a timely manner.
• Increase the internal impact of Takeda's data science work by identifying opportunities across therapeutic or disease areas and business units.
• Increase the external recognition of Takeda's data science work by participating in conferences, publishing work, and developing external collaborations.Minimum Requirements/Qualifications:
  • 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 or observational 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 or observational research, 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 Office products).
  • Excellent oral and written communications skills.
  • Strong project management skills.
  • Strong collaborative skills and ability to work with a cross-functional team.
  • Experience with safety, benefit-risk statistics, and/or patient reported outcomes preferred.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 a company match of charitable contributions
    • Family Planning Support
    • Flexible Work Paths
    • Tuition reimbursementBase Salary Range: $ 130,000 to $186,000. Employees may also be eligible for Short-Term and Long-Term Incentive benefits. 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. - - -The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.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.LocationsCambridge, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

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