Role  :  Data and Analytics Lead

Location :  Cambridge,MA

Duration :12 Months

Rate : $50/hr on C2C (Max)

Required Skills-

Additional Requirements:

 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

 Job Description :

 Data and Analytics Lead - Clinical Development 

The Clinical Data Sciences (CDS) department is strategically focused on clinical data, optimizing the data flow from CRF to Submission including but not limited to Data Management and Statistical Programming. The four areas of focus for CDS include Data Planning, Data Operations, Data and Analysis Infrastructure and Quality and Process Management.

The Data and Analytics Lead (DAL) role will:

• Oversees execution of data management and statistical programming/electronic submissions 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.
• Primary contact between CDS and clinical study management teams (SMT and/or Clinical Development Team representatives).
• Liaises directly with internal customers (CDS functions, GCO, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel) 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.

Additional Requirements:

• 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