About the position
AbbVie Data Science is recognized as a best-in-class team within its cross-industry peer group, dedicated to integrating people, processes, and technology to derive business value from clinical trials data. The operational model of this team is characterized by a strong emphasis on execution and innovation, which is crucial for the successful delivery of program- and study-level accountabilities assigned to Data and Statistical Sciences. The Program Lead I - Data Science plays a pivotal role in aligning the Data Science Study (DSS) teams with the overarching program and study strategies. This position is responsible for leading the DSS Study Team for assigned studies and serves as the primary operational lead from DSS, ensuring that all operational objectives are met efficiently. In this role, the Program Lead will coordinate with various DSS study teams, engaging and connecting global functional and cross-functional teams to achieve program and study objectives. The individual will utilize operational analytics and project management tools to optimize the execution of programs and studies, manage both internal and external resources, track study progress, and prepare comprehensive study status reports. A key aspect of this position involves anticipating and identifying potential issues that could impact timelines or quality, and developing viable options and solutions to address these challenges. The Program Lead is also responsible for ensuring compliance with federal regulations, local regulations, Good Clinical Practices, ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs). Staying updated on evolving regulations and guidelines related to clinical development is essential. Additionally, the role includes oversight of vendors, providing feedback on study operations, and mentoring Data Science Associates, which may involve indirect supervision of contract resources. Participation in innovation and process improvement initiatives within DSS and across functions is also a critical responsibility, along with contributing to the documentation of study execution "lessons learned" across various functions.
Responsibilities
- Aligns DSS study teams with program- and study-level strategies.
- Leads the DSS Study Team and represents DS as a member of the cross-functional study team for assigned studies.
- Acts as the single point of contact and accountable operational lead from DSS for assigned studies.
- Coordinates associated DSS study teams to meet operational objectives.
- Engages and connects global functional and cross-functional teams.
- Interacts with and influences cross-functional team members to achieve program and study objectives.
- Utilizes operational analytics and project management tools to optimize execution of programs and studies.
- Manages internal and external resources, tracks study progress, and prepares study status reports.
- Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
- Ensures adherence to federal regulations, local regulations, Good Clinical Practices, ICH Guidelines, and AbbVie SOPs.
- Participates in oversight of vendors and provides feedback related to study operations, issues, and trends in performance.
- Coaches and mentors Data Science Associates, including indirect supervision of contract resources.
- Participates in DSS and cross-functional innovation and process improvement initiatives.
- Contributes to study execution "lessons learned" across functions.
Requirements
- Bachelor's degree in business, management information systems, computer science, life sciences or equivalent.
- 3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience.
- Experience in data management, with some exposure to EDC, IRT, eCOA.
Nice-to-haves
- Master's degree
- PMP Certification or Lean Six Sigma Green Belt desired.
- Experience in managing a clinical trial from initiation through to completion.
Benefits
- Paid time off (vacation, holidays, sick)
- Medical/dental/vision insurance
- 401(k) to eligible employees
- Participation in short-term incentive programs
