Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
Data Science is accountable for the management and handling of the entire flow of clinical / patient data collected during clinical trials to provide the right data at the right time to all stakeholders involved for data review, monitoring, and decision making. Data Science is also accountable for statistical design and analysis of clinical trials, as well as preparation of data for submissions, integrated analyses, evidence generation, and submission defense. As such Data Science uses an eco-system of clinical data systems, analytical tools, and needs to ingest data from various electronic sources.
This position is accountable to define the strategy for the electronic clinical data flow using the available systems, and to provide a modern Statistical Computing Environment to all end users using closed and open-source software. In addition, the position provides excellence in creating automated / reusable solutions (eg macros) within the available systems to drive efficiency for end users.
The accountability includes identifying and implementing opportunities to use Artificial Intelligence, Machine Learning or automation solutions to optimize electronic data flow, review and analytics. That requires a close monitoring of solutions developed by vendors and proposing mature solutions for adoption.
This role is also responsible to be engaged and understand Astellas’ clinical trial needs for use of digital health tools and connection to source systems (eg EHR, imaging vendors) to enable use in Astellas trials.
The responsibility requires staying abreast of industry initiatives around Digital Data Flow and preparing Astellas for adoption.
Essential Job Responsibilities:
Strategy and Planning: Develop the solution strategy in line with the Corporate Strategic Plan, M&D priorities and Data science objectives; accountable for the DS Systems Portfolio; accountable for business case development (including cost / benefit analyses) and prioritization. Develop and implement strategies to realize value from solutions (e.g., changing processes, utilizing different resources).
Lead the annual planning and budgeting process for Data Science clinical data systems, analytical tools, and other digital health tools, partnering with MDSO and IS
Demand Management: Routinely consult with customers (e.g., Statistics, Data Management, Medical Writing, PF Development, Clinical Operations, etc.) and stakeholders (e.g., IS, MDSO, QA, etc.) to understand challenges, potential improvements and changing needs, and develop strategies to address the demand
Operational System Support: Manage system upgrades (e.g., annual Rave upgrade) and lead system maintenance activities (e.g., configuration changes, system issues) together with MDSO and IS
Innovate: Identify and evaluate solutions (e.g., pilot new tools or modules, enhance existing tools or macros, AI / ML, automation) that can fulfill needs. Responsible to understand and represent industry level best practices, identify improvement strategies, and to maintain a current overall knowledge of systems and solutions.
Implement: Provide focused, proactive business leadership for the implementation of new solutions. Drive adoption of best and efficient practices for agile system implementation and validation. Provide training in the use of new application.
Responsible to manage the portfolio of systems and tools used in data science (approximately 10-15 systems), including annual planning and prioritization of DS system investments
Create business cases for system upgrades or new systems, demonstrating quantitative benefits
Provide solutions to reduce the time from data generation to ingestion into Astellas technical environment to use of the data for decision making
Collaborates with DS vendor management to oversee vendor performance and is part of governance.
The position reports to the Head of Data Science (Division within Medical & Development)
The position will oversee a staff of 8-10 people
The position will be a part of the Data Science Leadership team, as a peer to the global heads of Statistical & Real World Data Science, Medical Writing, Data Management, and DS Business Operations Management
The position will work cross-functionally with MDSO and Information Systems globally to define and implement the strategy for clinical data flow, and optimization of the use of the ecosystem of tools and systems required to manage the clinical data process end-to-end, with the required analytical tools.
Minimally a Bachelor’s degree in computer science, information technology, data science or equivalent.
10-15 years of healthcare industry experience with significant knowledge of and experience with clinical data capture, warehousing, and analytics tools (EDC, eCOA, SAS, R, clinical workbench, visualization tools etc) and at least 3-5 years managing a suite of relevant systems and staff with accountability for managing budgets, timelines and resources.
In-depth personal experience and understanding of systems management with significant experience in the development, deployment, and/or maintenance of SAS, EDC, eCOA, IRT and other relevant information systems
Proven experience in Software Development Life Cycle including requirements/specifications development and/or user acceptance testing for computer systems including project management and timeline management skills. Experience with agile approaches.
Excellent interpersonal and negotiating skills; ability to work effectively with all levels of staff and leadership
Must have a successful track record in the hiring and retention of top talent resources who work optimally in a cross functional team and matrix environment with previous experience in people development activities
Strong leadership skills; communicates and demonstrates vision and commitment and the ability to successfully manage multiple tasks and competing priorities
Must be a strong and effective communicator (verbal, written, meeting facilitation and presentation) and strategic thinker across a system portfolio with the ability to problem solve and help individuals develop their own problem-solving skills and discipline.
Trained in Regulatory and System Compliance with applied GXP experience in pharmaceutical or biotechnology industry
Work experience across multiple cultures and countries is a plus
High level understanding of project management and quality assurance
Digital data flow optimization, EHR to EDC interfaces
Prior experience introducing automation solutions, application of AI and machine learning
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Data Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans