Remote Senior Biometrics Informatics & SCE Lead

Astrix; San Francisco (CA); Hybrid; USD 103,000 - 124,000; Full time

Job summary

Astrix, based in the United States, seeks a Senior Biometrics Informatics Consultant/SCE Implementation Lead to drive the evaluation, selection, and deployment of a new Statistical Computing Environment for clinical development. You will coordinate with Clinical Data Management, Biostatistics, Statistical Programming, and Clinical Pharmacology to define needs and validate the chosen solution.

The role requires hands-on experience with SAS and R in GxP contexts, vendor negotiations, and a track

Qualifications

• 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.

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

SAS programming

R programming

Vendor management

Requirements gathering

Cross-functional collaboration

Communication skills

Tools

Databricks

Git/Git-based workflows

Job description

Astrix, based in the United States, seeks a Senior Biometrics Informatics Consultant/SCE Implementation Lead to drive the evaluation, selection, and deployment of a new Statistical Computing Environment for clinical development. You will coordinate with Clinical Data Management, Biostatistics, Statistical Programming, and Clinical Pharmacology to define needs and validate the chosen solution.

The role requires hands-on experience with SAS and R in GxP contexts, vendor negotiations, and a track