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:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as an Associate Director, Programming in Cambridge, MA, where you will oversee and direct the work for a team of programmers working on statistical programming activities that are not unique to a therapeutic area with implementation of strategies to build efficient processes and resourcing plans. You will support and drive statistical programming strategies and provide statistical programming oversight to deliver deliverables to ensure quality and timeliness. You will also show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners.As part of the Statistical & Quantitative Sciences team, you will report to the Director, Programming. Takeda SQS is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistical programming function, exceptional leaders and innovators. 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.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:
Oversee and direct the work of the Clinical trial disclosure programming team (within the Programming Center of Excellence) in the delivery of disclosure results to ct.gov and Eudract.
Conduct hands-on programming activities in specialized data (e.g., Biomarker, PK).
Strong technical skills to implement standard data structures and analysis datasets (e.g., CDISC) and supporting deliverables efficiently (e.g, Standard code, AI and ML applications).
Collaborate with Clinical Trial Transparency Teams to implement data anonymization of patient level data.
Leads process improvement initiatives.
Existing internal and external presence on varied statistical programming topics.
Support Clinical Trial Disclosure Programming and data anonymization.
Provides technical leadership, organize and ensures adequate statistical programming support for assigned projects
Oversee external resources and provides technical leadership with skills including: excellent oral/written communications skills, strong inter-personal, vendor management, project management, collaborative skills, ability to work with a cross-functional team.
Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions.
Work with ICH-GCP guidelines for clinical trial disclosure rules (EMA Policy 0070, Health Canada, USFDA) such as FDAAA 801, EudraCT for Data Sharing.
Subject Matter Expert (SME) in anonymization of patient-level data tables and datasets according to company standard redaction ruleset.
Leads assigned clinical projects, advancing and implementing Statistical Programming strategies to ensure efficient and quality execution of the deliverables by assisting Programming CoE lead.
A SME in the special data types (e.g., Biomarker, PK) Provide expert input into standardization efforts related to special data types and be an early adopter of the standards as well as contributing to the end-to-end data flow and process for specialized data.
Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
Accountable for decision making for the statistical programming function.
Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution.
Ability to distil complex technical ideas in simple comprehensible terms in order to influence decisions and outcomes.
Key decision maker in asset level strategies and enabling tactical implementation.
Proactively creates and implements sub-strategies to enable the promotion of SQS and DSI vision and mission within TAUs, BUs, and R&D functions.
Minimum Requirements/Qualifications:
PhD with 8-12+ years of industry related experience; or MS with 12+ years of industry related experience or BS with 14+ years of industry related experience.
Proven track record of leading business process transformations and organizational culture change as well as driving programming expertise on programs with complex business deliverables.
Operational experience in pharmaceutical drug development with significant direct exposure to clinical development.
Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
Track record of successful leadership, management, and development of statistical programming teams.
Ability to recommend technical solutions using a wide variety of software (e.g. SAS, R, Python).
Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
Experience in machine learning workload and AI powered products is plus.
Ability to work in a global ecosystem (internal and external) with a high degree of complexity.
Creates and embeds programming best practices and standardization for novel data such as real world data, digital data, wearable device data.
Proven skills as an effective team player who can engender credibility and confidence within and outside the company.
Passionate to keep up with the industry trends and approaches to solve technical problems.
More 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.Takeda Compensation and Benefits SummaryWe 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:New Jersey - VirtualU.S. Base Salary Range:$149,100.00 - $234,300.00The 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 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.LocationsNew Jersey - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote