Director, Technical Solutions – Statistical Programming

Green Key Resources; Cambridge (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

Green Key Resources seeks a Director of Technical Solutions to lead the technology and analytics platforms supporting clinical development and statistical programming in the Cambridge area.

The role oversees AWS-based statistical programming environments, clinical data systems, and advanced analytics, driving automation, innovation, and AI integration within a regulated pharma/biotech setting. Strong leadership and cloud expertise are essential.

Qualifications

• Bachelor's degree or higher in a quantitative or computer science discipline.
• 15+ years leading technical projects or teams in pharma/biotech/CDISC environments.
• Strong experience with AWS cloud infrastructure for statistical programming or clinical data analytics.
• In-depth knowledge of statistical programming environments, clinical data systems, and clinical development workflows.
• Experience with data platforms, analytics infrastructure, data integrations, or reporting solutions.
• Understanding of SAS, R, and/or Python programming environments.
• Experience collaborating with IT and cross-functional teams on requirements, implementation, and validation.
• Knowledge of CDISC standards and clinical data workflows from CRF to CSR.
• Experience managing technical teams, vendors, or service providers.
• Strong grasp of GCP/ICH, GxP, 21 CFR Part 11, and computerized system validation.

Responsibilities

• Lead strategy, implementation, and optimization of AWS cloud platforms for Statistical Programming, Biostatistics, Data Science, and Clinical Development.
• Oversee design, validation, integration, and maintenance of clinical data and analytics systems.
• Develop technical standards, governance policies, SOPs, and best practices for compliant statistical programming environments.
• Drive automation, advanced analytics, data visualization, and AI-enabled solutions.
• Lead implementations and integrations involving SAS, R, Python, clinical databases, and data analytics platforms.
• Partner with IT, Clinical Development, Biostatistics, Statistical Programming, and Quality teams to improve data workflows.
• Ensure systems meet regulatory requirements (GCP/ICH, 21 CFR Part 11, GxP).
• Evaluate emerging technologies, manage vendor relationships, and oversee external partners.
• Lead technical teams, project planning, budgeting, and system implementation initiatives.

Skills

AWS cloud infrastructure

Statistical programming

Leadership

SAS

R

Python

CDISC standards

GxP and validation

Cloud architecture

Education

Bachelor's degree in Computer Science/Statistics/Mathematics/Information Sciences or related field

Tools

SAS

R

Python

Job description

Director, Technical Solutions – Statistical Programming

Location: Cambridge, MA (Local candidates or those willing to relocate)

Industry: Pharmaceutical / Biotechnology

Employment: Full-Time, Permanent

Position Overview

We are seeking an experienced Director of Technical Solutions to lead the technology, cloud infrastructure, and analytics platforms supporting clinical development and statistical programming.

This role will oversee AWS-based statistical programming environments, clinical data systems, and advanced analytics solutions while driving innovation, automation, and AI integration.

The ideal candidate will bring a strong combination of statistical programming knowledge, clinical data technology expertise, AWS cloud experience, and technical leadership within a regulated pharmaceutical or biotechnology environment.

Key Responsibilities

• Lead the strategy, implementation, and optimization of AWS cloud platforms supporting Statistical Programming, Biostatistics, Data Science, and Clinical Development.
• Oversee the design, validation, integration, and maintenance of clinical data and analytics systems.
• Develop technical standards, governance policies, SOPs, and best practices for compliant statistical programming environments.
• Drive innovation through automation, advanced analytics, data visualization, and AI-enabled solutions.
• Lead implementations and integrations involving SAS, R, Python, clinical databases, and data analytics platforms.
• Partner with IT, Clinical Development, Biostatistics, Statistical Programming, and Quality teams to improve data workflows.
• Ensure systems meet GCP/ICH, 21 CFR Part 11, GxP, and validation requirements.
• Evaluate emerging technologies, manage vendor relationships, and oversee external technical partners.
• Lead technical teams, project planning, budgeting, and system implementation initiatives.

Required Qualifications

• Bachelor's degree in Computer Science, Statistics, Mathematics, Information Sciences, or a related discipline.
• 15+ years of experience in pharmaceutical, biotechnology, or CRO environments leading technical projects or teams delivering clinical data and analytics solutions.
• Strong experience with AWS cloud infrastructure supporting statistical programming or clinical data analytics.
• In-depth knowledge of statistical programming environments, clinical data systems, and clinical development workflows.
• Experience implementing or managing clinical data platforms, analytics infrastructure, data integrations, or reporting solutions.
• Understanding of SAS, R, and/or Python programming environments.
• Experience working with IT and cross-functional teams on technical requirements, system implementation, and validation.
• Knowledge of CDISC standards and clinical data workflows from CRF through CSR.
• Experience managing technical teams, vendors, or functional service providers.
• Strong understanding of GCP/ICH, GxP, 21 CFR Part 11, and computerized system validation.
• Demonstrated ability to lead complex technical initiatives and establish standards, governance, and best practices.

Preferred Qualifications

• Advanced degree, MBA, or Project Management certification.
• Hands-on experience with SAS, R, or Python.
• Experience implementing cloud-based statistical programming platforms or migrating legacy environments to AWS.
• Experience integrating generative AI, automation, or advanced analytics into clinical data workflows.
• Experience with EDC platforms, clinical data warehousing, dashboards, and visualization tools.
• Experience developing SOPs and leading organizational change management initiatives.

Ideal Candidate Profile

A senior technical leader with a background in statistical programming infrastructure, clinical data platforms, or quantitative sciences technology who has progressed into enterprise-level technology strategy and implementation.

This is not a traditional hands-on Statistical Programming Director role. The primary focus is technical infrastructure, AWS cloud platforms, systems integration, governance, and innovation supporting clinical development and statistical programming teams.