Note: The job is a remote job and is open to candidates in USA. Astrix’s client is seeking a Senior Biometrics Informatics Consultant to lead the evaluation, selection, implementation, and validation of a new Statistical Computing Environment for clinical development. The role partners with clinical and technical teams, evaluates vendors, supports SAS and Python workflows, and ensures compliance with GxP, computer system validation, and SOP requirements.
Responsibilities
- Lead requirements gathering and current-state assessment for a new Statistical Computing Environment
- Evaluate potential SCE vendors, including coordinating vendor demonstrations, technical assessments, pilots, and selection activities
- Develop system/interface maps and vendor evaluation scorecards to support the selection process
- Partner with internal stakeholders to develop and evaluate RFPs and support vendor negotiations and purchasing activities
- Lead the technical configuration, implementation, integration, and validation of the selected SCE
- Collaborate with Clinical Data Management, Statistical Programming, Biostatistics, and Clinical Pharmacology teams to ensure the solution meets clinical development needs
- Support clinical programming workflows across SAS and Python environments
- Serve as the technical subject-matter expert throughout implementation, validation, user acceptance, and transition to ongoing operations
- Partner with internal teams and external vendors to troubleshoot technical and workflow challenges
- Ensure implementation activities align with GxP requirements, computer system validation expectations, and SOP-driven processes
- Support successful handoff of the new environment to internal stakeholders and operational teams
Skills
- 5+ years of experience supporting or leading the implementation of Statistical Computing Environments within drug development
- Demonstrated experience with vendor evaluation, selection, and implementation of validated systems within a biotech or pharmaceutical environment
- Must be Authorized to work in the United States without sponsorship
- Strong understanding of SAS and R programming practices within clinical development
- Experience gathering and translating requirements from Biostatistics, Statistical Programming, Clinical Pharmacology, and/or Clinical Data Management teams
- Experience working within GxP-regulated environments, including computer system validation and SOP-driven processes
- Strong project coordination, stakeholder management, and communication skills
- Ability to work effectively across technical, clinical, and vendor teams
- Experience with Databricks
- Knowledge of clinical data standards
- Experience with Git/Git-based development workflows
- Experience with AI-assisted SAS or R coding
- Experience supporting modernization or migration from legacy statistical computing platforms
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