Director, Technical Solutions

Alnylam Pharmaceuticals•Cambridge, MA

1d•$200,700 - $271,500•Hybrid

About The Position

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.

Requirements

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
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

Nice To Haves

MBA, advanced degree and / or Project Management certification preferred

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.