Takeda is advancing an exciting product pipeline and wants to ensure that we have the infrastructure and talent in place to support it. Our overall goal is to get our therapeutics to patients safely and quickly via an optimized operational model and integrated clinical data pipeline.
The Project Analyst is responsible for helping to execute projects related to the systems, process, and governance for clinical trial data as part of a transformational data program. This data program will include an integrated data flow with end-to end control of data, internalization of numerous systems and processes, broad enablement of automation and near-time data access, efficient data review and query, and enablement of disruptive technologies for next-gen trial designs and insights. The data program will encompass all systems, platforms and tools involved in the collection, processing, review, analysis, and downstream reporting or consumption of clinical trial data and will be inclusive of all Takeda therapeutic areas and relevant business units.
As a Project Analyst you will:
Contribute to data-driven projects through hands-on development and testing
Be an active team member in translating scientific and business questions into data and analytic exploration
Understand end-to-end flow, development partners, and dependencies that build strong relationships and partnerships with technology partners, data providers, and users
Seek out new perspectives and be alert for opportunities to learn and apply skills and develop new talents
Stay current on industry trends, trade-offs, design decisions, and alternate views and approaches across technology, science, and operations.
DELIVERY & BUSINESS ACCOUNTABILITIES
The Project Analyst is expected to:
Help execute the clinical data transformation to support Takeda R&D’s vision to create a development engine and ecosystem that provides optimal clinical data control and quality in a predictable, automated & cost-effective way
Assist in designing multi-faceted business process mapping to inform future-state clinical data flow and system and architecture design; Work with team leadership to ensure business impact is well-understood and accounted for within broader future fit development workstreams
Support engagement with clinical data vendors, systems, platforms, and tools to support a transformed global data program
Help define and embed appropriate quality oversight and governance tools and processes throughout data program in accordance with R&D policies
Engage with stakeholders for all components of the data pipeline from vendors, systems, data models, analysis platforms and other tools within clinical data ecosystem
Help facilitate the transition plans from former state to transformed state and contribute to future-state processes
Help inform the strategic vision for long-term delivery innovation
Communicate challenges and successes within project groups
Leverage strong interpersonal skills in supporting others on the analyst team
CORE ELEMENTS RELATED TO THIS ROLE:
Highly cross-functional role with broad scope of responsibilities
High visibility and critical impact on the future of the business
DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise:
Exercises judgment in planning, organizing and performing work; monitors performance and reports status within area of responsibility
Employs sound analytical skills and is detail oriented
Monitor activity to ensure compliance
Works within a team and as an individual contributor in a fast-paced, changing environment.
Multitasks, prioritizes and meets deadlines in a timely manner
Communicates clearly, persuasively conveying both ideas and data, verbally and in writing
Effectively represents program in negotiations with the ability to resolve conflict in a constructive manner
Incorporates feedback and ensures decisions are implemented swiftly to yield flawless execution
Builds strong relationships and collaborate effectively with other interfacing Takeda functions
Helps to inform organizational change and continuous innovation
Assists in identifying opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
Serves as a role model, demonstrating respect and inclusion, creating a culture that fosters innovation
Works in a global ecosystem (internal and external) with a high degree of complexity
Recognizes broad, enterprise level perspective
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
MS with 3+ years experience in pharmaceutical industry or health related field (exceptional Bachelors degree considered)
Experience working in rigorous analytic environments where exploration of alternate approaches and novel solutions are necessary to address unmet needs
Experience working with clinical data or clinical data systems such as EDC, IRT, Statistical Analysis Environments, CTMS and eTMF
Experience in the use and application of data science tools, toolkits, algorithms, and analytics to meet complex business needs
Familiarity in diverse data architectures and analytic approaches, computing models, and data structures
Interest in advanced database technologies to include big data methodologies, NoSQL and graph structures, modern software languages, precision security models, analytic environments, and DevOps tools
Good knowledge of statistical programming languages (e.g. SAS) and statistical compute environments
Technical expertise (e.g. Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS.
Expertise in the requirements and technology required to support electronic data capture and electronic submissions.
Basic knowledge of medical and statistical terminology
Tolerance of ambiguity and willingness to work through complex issues
Ability to develop solutions to complex issues and challenges
Promotes teamwork while working through solutions
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.