Director, Technical Solutions

Director, Statistical Programming Technical Solutions

Summary of Key Responsibilities

• Designs and leads Quantitative Sciences data and analytics systems strategy and/or technical development initiatives including systems and technology integration, data sharing, analysis, transfer/access and storage platforms or utilities.

• Establishes Quantitative Sciences technical direction, standards, and governance policies for analytical solutions and platforms, as well as best practices for efficient and inspection ready delivery across the data flow.
• Lead the strategic vision, implementation, and continuous evolution of the AWS cloud platform supporting Statistical Programming, Biostatistics, Epidemiology, Data Science, and Clinical Development functions.
• Oversee the design, deployment, validation, and lifecycle management of AWS-hosted programming and analytics environments within regulated GxP settings.
• Promotes technical innovation to drive the development of data, analysis and visualization solutions within a clinical data environment.
• Develop strategies in collaboration with Data Science team for integrating generative AI and other advanced analytics tools into statistical programming workflows while ensuring regulatory compliance and appropriate validation.
• Leads technical assessments of vendor products or new technologies; manages and establishes relationships with technical vendors to support business needs.

• Collaborates with Clinical Development Operations, IT and other functional leaders to ensure organizational effectiveness / efficiencies from systems and technology platforms.

• Partners with the IT Validation / QA organizations to ensure compliance of clinical data systems and processes to regulatory requirements.
• Collaborates with IT on technical project prioritization, forecasting, estimation, and budgeting.

• Facilitates change management activities and training for key systems and processes.

Qualifications

• Minimum 15 years’ industry experience (Pharmaceutical, Biotech, CRO) leading technical projects and/or supervising teams to deliver data/analytics solutions;
• Demonstrated technical expertise with clinical databases, AWS/EDC platforms, data imports/integrations, data analytics platforms and/or data visualization tools; advanced programming and analytical skills using SAS, R and Python an asset.
• Experience driving data solutions projects or system implementations (i.e., data dashboards, R/SAS/data analytics infrastructure, data warehousing, data visualization and/or risk-based data review tools/systems) with clinical team members;
• Demonstrated experience working with IT and cross-functional counterparts in evaluating and implementing clinical data systems, constructing technical business requirements, specifications and supporting validation documentation
• Experience managing technical teams (FTEs, Functional Service Providers or vendors); 
• Demonstrated leadership in implementing solutions within the clinical data flow, understanding of CDISC standards, and technologies/utilities in support of Quantitative Sciences data flow (from CRF to CSR);
• Detailed knowledge of data management, statistical programming environments, processes, procedures, and roles;
• Detailed knowledge of data management, statistical programming environments, processes, procedures, and roles;
• Experience developing SOPs, Standards or implementing technical best practices;
• Experience overseeing vendors in the delivery of technical solutions, including development of quality and performance metrics;
• Excellent written and oral presentation and interpersonal, organizational, analytical, project management and multi-tasking skills;
• Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, Validation requirements;
• Bachelor’s Degree required in areas of computer science, statistics, mathematics or information sciences, MBA, advanced degree and / or Project Management certification preferred

• Clear alignment with Alnylam Core Values:
  • Commitment to People
  • Innovation and Discovery
  • Sense of Urgency
  • Open Culture
  • Passion for Excellence

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