Director, Technical Solutions
Alnylam Pharmaceuticals
August 06, 2026
Remote friendly (Cambridge, MA)
United States
IT
Director, Statistical Programming Technical Solutions
Summary Of Key Responsibilities
- Design and lead Quantitative Sciences data and analytics systems strategy and/or technical development initiatives, including integration, data sharing, and storage/transfer platforms.
- Set technical direction, standards, and governance for analytical solutions and platforms; establish best practices for efficient, 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.
- Oversee design, deployment, validation, and lifecycle management of AWS-hosted programming and analytics environments in regulated GxP settings.
- Drive technical innovation for data, analysis, and visualization solutions in a clinical data environment.
- Develop strategies to integrate generative AI and advanced analytics tools into statistical programming workflows with regulatory compliance and appropriate validation.
- Conduct technical assessments of vendors/products/new technologies and manage vendor relationships.
- Collaborate with Clinical Development Operations, IT, and other leaders to ensure platform effectiveness/efficiencies.
- Partner with IT Validation/QA to ensure compliance with regulatory requirements.
- Collaborate with IT on technical project prioritization, forecasting, estimation, and budgeting.
- Facilitate change management and training for key systems and processes.
Qualifications
- Minimum 15 years industry experience (Pharma, Biotech, CRO) leading technical projects and/or supervising teams delivering data/analytics solutions.
- Expertise with clinical databases; AWS/EDC platforms; data imports/integrations; analytics/visualization tools; advanced SAS, R, and Python skills (asset).
- Experience implementing data solutions (e.g., dashboards, data analytics infrastructure, data warehousing, visualization/risk-based review tools) with clinical teams.
- Experience evaluating/implementing clinical data systems, developing technical requirements/specifications, and supporting validation documentation.
- Experience managing technical teams (FTEs, functional service providers, or vendors).
- Leadership implementing solutions across clinical data flow; CDISC standards knowledge; CRF to CSR data flow understanding.
- Knowledge of data management and statistical programming environments/processes/roles; experience developing SOPs/standards and technical best practices.
- Experience overseeing vendors and defining quality/performance metrics.
- Strong presentation, interpersonal, organizational, analytical, project management, and multitasking skills.
- Advanced knowledge of GCP/ICH, 21 CFR Part 11, and validation requirements.
- Bachelor’s degree required (CS, statistics, math, or information sciences); MBA/advanced degree and/or Project Management certification preferred.
Summary Of Key Responsibilities
- Design and lead Quantitative Sciences data and analytics systems strategy and/or technical development initiatives, including integration, data sharing, and storage/transfer platforms.
- Set technical direction, standards, and governance for analytical solutions and platforms; establish best practices for efficient, 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.
- Oversee design, deployment, validation, and lifecycle management of AWS-hosted programming and analytics environments in regulated GxP settings.
- Drive technical innovation for data, analysis, and visualization solutions in a clinical data environment.
- Develop strategies to integrate generative AI and advanced analytics tools into statistical programming workflows with regulatory compliance and appropriate validation.
- Conduct technical assessments of vendors/products/new technologies and manage vendor relationships.
- Collaborate with Clinical Development Operations, IT, and other leaders to ensure platform effectiveness/efficiencies.
- Partner with IT Validation/QA to ensure compliance with regulatory requirements.
- Collaborate with IT on technical project prioritization, forecasting, estimation, and budgeting.
- Facilitate change management and training for key systems and processes.
Qualifications
- Minimum 15 years industry experience (Pharma, Biotech, CRO) leading technical projects and/or supervising teams delivering data/analytics solutions.
- Expertise with clinical databases; AWS/EDC platforms; data imports/integrations; analytics/visualization tools; advanced SAS, R, and Python skills (asset).
- Experience implementing data solutions (e.g., dashboards, data analytics infrastructure, data warehousing, visualization/risk-based review tools) with clinical teams.
- Experience evaluating/implementing clinical data systems, developing technical requirements/specifications, and supporting validation documentation.
- Experience managing technical teams (FTEs, functional service providers, or vendors).
- Leadership implementing solutions across clinical data flow; CDISC standards knowledge; CRF to CSR data flow understanding.
- Knowledge of data management and statistical programming environments/processes/roles; experience developing SOPs/standards and technical best practices.
- Experience overseeing vendors and defining quality/performance metrics.
- Strong presentation, interpersonal, organizational, analytical, project management, and multitasking skills.
- Advanced knowledge of GCP/ICH, 21 CFR Part 11, and validation requirements.
- Bachelor’s degree required (CS, statistics, math, or information sciences); MBA/advanced degree and/or Project Management certification preferred.