Sr. Clinical Informatics Consultant - (Remote)

Astrix; New York (NY); Hybrid; USD 103,000 - 124,000; Full time

Job summary

Astrix seeks a Senior Biometrics Informatics Consultant to lead the evaluation, selection, and implementation of a new Statistical Computing Environment for clinical development. Remote with occasional onsite in San Francisco (1-2x a month).

The role collaborates with Clinical Data Management, Biostatistics, and Programming teams to define requirements, assess vendors, validate the system, and support SAS and Python workflows.

Qualifications

• 5+ years leading Statistical Computing Environment implementations in drug development.
• Experience with vendor evaluation, selection, and implementation of validated systems in biotech/pharma.
• Authorized to work in the United States without sponsorship.
• Strong SAS and R programming within clinical development.
• Experience translating requirements from Biostatistics, Statistical Programming, Clinical Pharmacology, and/or Clinical Data Management.
• Experience in GxP-regulated environments, including computer system validation and SOP-driven processes.
• Excellent project coordination and communication across teams.

Responsibilities

• Lead requirements gathering and current-state assessment for a new Statistical Computing Environment.
• Evaluate potential SCE vendors, coordinating demos, 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 evaluation

Project coordination

Stakeholder management

GxP experience

Communication skills

Python

Tools

Databricks

Git

SAS

Python

Job description

Pay Rate Low: $75 | Pay Rate High: $90

Our client is seeking a Senior Biometrics Informatics Consultant to lead the evaluation, selection, and implementation of a new Statistical Computing Environment supporting clinical development.

Title: Senior Biometrics Informatics Consultant/SCE Implementation Lead (Remote)

Pay Rate: $75-$90/hr ( + Benefits)

Contract Duration: 12 months

Location: US based, Occasional onsite support in San Francisco is required (1-2x a month)

Position Overview

This consultant will partner closely with Clinical Data Management, Statistical Programming, Biostatistics, and Clinical Pharmacology teams to assess current-state capabilities, define business and technical requirements, evaluate potential vendors, and lead the implementation and validation of the selected solution.

Key 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.

Required 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.

Preferred Qualifications

• 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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