Role OverviewResponsible for executing on strategy to scale and accelerate biometrics deliverables by leveraging existing standards and processes to implement automation-centric, AI-enabled workflows that result in regulatory compliant data collection, analysis, and reporting. This role works closely with project leads in Data Management, Statistical Programming and Biostatistics to operationalize existing data and analysis requirements into automation-centric, AI-enabled workflows in a regulatory compliant framework deeply rooted in reusable metadata, lifecycle governance, content reuse and responsible-AI controls.
What You Will Do
Implement and champion continuous improvement of foundational standards that enable automation and consistent execution across studies, drive standards implementation and operationalization aligned to CDISC expectations, support design and quality of submission-critical outputs, build and deploy low/no-code automations that improve standards adherence and consistency, handoff quality between Data Management, Statistical Programming and Biostatistics, repeatability of analysis and reporting workflows, inspection readiness through controlled outputs and documentation.
Why It Might Be a Fit
Considered an expert within the company and may have external presence in area of expertise, applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively, ability to work as part of and lead multiple teams, sees broader picture and longer-term impact on division/company.
Requirements
- BS/BA degree AND 10+ years of relevant biotech/pharma/CRO clinical development experience
- Master’s degree AND 8+ years of related biotech/pharma/CRO clinical development experience
- PhD AND 5+ years of related biotech/pharma/CRO clinical development experience
- Deep knowledge of CDASH and CDISC industry standards (e.g., SDTM, ADaM, Define.xml) and the increasingly complex regulatory requirements for delivering regulatory quality data
- Experience leveraging standards to create processes that facilitate automation and AI-driven solutions to optimize Analytic and Data Sciences deliverables
- Advanced SAS or R proficiency; +Python and SQL strongly preferred
- Experience with Medidata Rave EDC build and content reuse (CRF standards, edit checks, libraries) and downstream readiness
- Deep knowledge of GxP expectations, data integrity, audit trails, and partnering with IT/Quality on validation
Benefits
- Annual base salary $171,800.00-$235,000.00
- Annual bonus with a target of 30% of the earned base salary
- Eligibility to participate in our equity based long term incentive program
- Retirement savings plan (with company match)
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
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