Data Science Program Lead Ii

Job Description
Key Responsibilities
Align Data &
Statistical Science (DSS) study teams with program &
study-level strategies.
Lead the DSS Study Team &
represent DSS as a member of cross-functional study team.
Act as single point of contact &
accountable operationallead from DSS. Coordinates associated DSS study teams to meet operational objectives.
Utilize clinical trial systems including Electronic Data Capture (EDC), Interactive Response Technology (IRT) &
Clinical Trial Management Systems (CTMS).
Utilize understanding of Laboratory data, Clinical Outcomes Assessments (COA/eCOA), ECG, IRT, Pharmocokinetic &
other external data types.
Engage &
connect global functional &
cross-functional teams at study level. Interact with &
influence cross-functional team members to achieve program objectives.
Plan, coordinate, &
deliver data managementtasks within timeline.
Utilize operational analytics &
project management tools to optimize execution of programs &
studies, manage internal &
external resources, track study progress, &
prepare study status reports.
Author, revise, &
review data management related plans &
documentation, including Data Management Plan, Data Review Plan, Electronic Case Report Form (eCRF), &
completion Guidelines.
Anticipate &
identify issues that could affect timelines or quality &
develop options &
solutions, identify &
mitigate risk and contribute to Risk Assessment &
Management Plan.
Ensure adherence to federal regulations &
applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), &
functional quality standards.
Perform project management skills including metrics analysis &
reporting methodologies.
Keep abreast of new &
/or evolving local regulations, guidelines &
policies related to clinical development.
Participate as DSS study owner in regulatory inspections &
internal quality audits.
Participate in oversight of vendors &
provide feedback related to clinical trial operations, issues, &
trends in performance.
Utilize reporting &
data visualization tools such as Spotfire, J-Review, Business Objects &
/or SAS to generate datareview listings, also, project management tools such as Microsoft Project, Smartsheet or equivalent.
Responsible for coaching &
mentoring team members.
Lead DSS innovation &
process improvement initiatives &
participates in cross-functional initiatives.
Conduct study execution across functions.
Conduct indirect supervision of employees as well as supervision of work of contract resources.