Client: Direct Client
Location: Cambridge, MA
Job Title: Data & Analytics Lead
Duration: 1 Year+ (Possible Extension)
Responsibilities
The World Wide Medical Biostatistics department is a distinct biostatistics group within the World Wide Medical organization that deals primarily with late phase clinical development in marketed compounds. The Data and Analytics Lead (DAL) role has a focus on Late Phase Clinical Development, including post-marketing and Phase IV studies.
Primary Duties
• The Data and Analytics Lead manages the end to end clinical data flow (data acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR) of Clinical Data) and ensures timely project execution; recognized as an operational specialist in data flow and study execution by all functions.
• Partners with key study team members to facilitate implementation of a robust and clear Data Strategy for assigned studies.
• Uses phase, TA and operational knowledge to establish study level operational plans and oversees CROs and other vendors to ensure timely execution.
• Develops study level quality plans and ensures adherence and consistent execution across the data flow.
• Collaborates with Program DALs to ensure alignment of study operational plans with program goals and for execution and quality.
• Develops timeline and project manages all end to end data and statistical programming and submission deliverables in collaboration with cross functional team members and vendors.
• Oversees execution of data management and statistical programming deliverables.
• Interprets and applies data strategy, verifies consistency and usage of data, results and submissions standards, Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress.
• Accountable for overall quality of study data.
• Develops risk mitigation or action plans and oversees execution when appropriate.
Liaises directly with internal customers (CDS functions, GCO, Biostatistics, and Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel, all other external Partners (affiliates, etc.).
• Serves as Subject Matter Expert for data, reporting, and analysis process definition, improvement, and innovation as needed.
• Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed.
Support study-level audit and inspection readiness activities as needed.
• Serve as project manager on special projects and initiatives; partners with Statistical Programming, Vendor Management and Quality depending on type of project.
Education & Experience
• Bachelor’s degree, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
• 8+ years relevant work experience with a focus on data management and/or data analysis
• Deep understanding of drug development and biopharmaceutical industry required
• Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
• High attention to detail including proven ability to manage multiple, competing priorities
• Experience overseeing outsourced clinical trials work
• Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor
• Deep knowledge of clinical data management and statistical programming outsourcing with full-service, global CROs and FSPs
• Demonstrated ability to influence without authority
• Excellent written and oral communication skills
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