Associate Director, Analysis Oversight Lead RWE Safety: Inflammation
Gilead Sciences
9 hours ago
Remote friendly (Parsippany, NJ)
United States
Clinical Research and Development
Position Summary
- Oversight of timeliness and quality of safety programming and analysis deliverables supporting the CDS-RWE Inflammation therapeutic area.
- Report to the CDS-RWE Safety Epidemiology Lead; partner with CDS-RWE scientific leads and Patient Safety stakeholders to translate safety analysis requirements into high-quality, compliant programming and analysis deliverables.
- Primary point of contact for analysis and service vendors; responsible for planning, execution, and quality acceptance of safety analysis deliverables.
- Manage complex analytical workflows in a GxP-compliant programming environment to meet time-critical deadlines.
Key Responsibilities
- Track, prioritize, and deliver programming and analysis deliverables to meet pharmacoepidemiology and safety requirements across the TA portfolio.
- Ensure deliverables are generated using a compliant and traceable process.
- Manage vendor performance; escalate risks impacting compliance or timeliness.
- Oversee vendor plans, performance, and quality checks for programming, analysis, and other deliverables.
- Own end-to-end oversight of analysis deliverables; ensure timely, high-quality completion aligned to TA priorities; proactively identify and mitigate risks.
- Monitor translation of requirements into analysis specifications and deliverables by vendors/service providers.
- Monitor/review quality of deliverables (specifications, programs, cohorts, feasibility results, analysis results, publications, abstracts, and other outputs).
- Ensure vendor/service provider processes meet quality and regulatory requirements.
- Ensure locking/archiving of programming and analysis deliverables and outputs, as appropriate.
- Monitor utilization and coordinate assignment of analyses to vendors/service providers to meet quality and timeline priorities.
- Resolve quality, scope, and timeliness issues via escalation.
- Maintain regular communication with vendors/service providers on priorities and milestones.
- Ensure onboarding of vendors/service providers to analysis tools, programming environments, and access to observational data.
- Identify/document process improvement opportunities (e.g., optimization, increased standardization).
- Collaborate with other oversight roles in other TAs for uniformity and consistency.
Basic Qualifications
- Bachelor’s degree and 10+ years of relevant experience; OR
- Master’s degree and 8+ years of relevant experience; OR
- PhD and 2+ years of relevant experience.
Qualifications (Required/Preferred)
- 5+ years as a data scientist or data analyst generating analysis deliverables for observational research.
- Preferred: MS or more advanced degree in Computer Science, Data Science, Biostatistics, or Epidemiology (or equivalent). Required: BS degree in one of these fields (or equivalent).
- Hands-on experience with primary data and real-world data sources using multiple programming tools (e.g., SAS, R) in GxP-compliant environments.
- Demonstrated experience leading/managing programmers and data analysts; balance priorities and timelines in a matrixed environment.
- Proven ability to review programs and analysis outputs for quality, completeness, and best practices.
- Ability to communicate scope/requirements/expectations/standards for time-critical deliverables and to communicate/interpret analysis results.
- Strong data-driven problem-solving and cross-functional collaboration (program, study, functional teams, vendor resources).
- Strong written and verbal communication skills.
- Preferred: Understanding of the RWE regulatory landscape.
- Preferred: Experience with international datasets and/or Common Data Models (e.g., OMOP).
People Leader Accountabilities
- Create Inclusion.
- Develop Talent (coach employees; ensure feedback/insight for growth and performance).
- Empower Teams (align goals/purpose/objectives; remove barriers; connect to broader ecosystem).
Benefits
- Salary range: $165,495.00 - $214,170.00.
- Discretionary annual bonus and discretionary stock-based long-term incentives (eligibility varies by role).
- Paid time off.
- Benefits include company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.
- Oversight of timeliness and quality of safety programming and analysis deliverables supporting the CDS-RWE Inflammation therapeutic area.
- Report to the CDS-RWE Safety Epidemiology Lead; partner with CDS-RWE scientific leads and Patient Safety stakeholders to translate safety analysis requirements into high-quality, compliant programming and analysis deliverables.
- Primary point of contact for analysis and service vendors; responsible for planning, execution, and quality acceptance of safety analysis deliverables.
- Manage complex analytical workflows in a GxP-compliant programming environment to meet time-critical deadlines.
Key Responsibilities
- Track, prioritize, and deliver programming and analysis deliverables to meet pharmacoepidemiology and safety requirements across the TA portfolio.
- Ensure deliverables are generated using a compliant and traceable process.
- Manage vendor performance; escalate risks impacting compliance or timeliness.
- Oversee vendor plans, performance, and quality checks for programming, analysis, and other deliverables.
- Own end-to-end oversight of analysis deliverables; ensure timely, high-quality completion aligned to TA priorities; proactively identify and mitigate risks.
- Monitor translation of requirements into analysis specifications and deliverables by vendors/service providers.
- Monitor/review quality of deliverables (specifications, programs, cohorts, feasibility results, analysis results, publications, abstracts, and other outputs).
- Ensure vendor/service provider processes meet quality and regulatory requirements.
- Ensure locking/archiving of programming and analysis deliverables and outputs, as appropriate.
- Monitor utilization and coordinate assignment of analyses to vendors/service providers to meet quality and timeline priorities.
- Resolve quality, scope, and timeliness issues via escalation.
- Maintain regular communication with vendors/service providers on priorities and milestones.
- Ensure onboarding of vendors/service providers to analysis tools, programming environments, and access to observational data.
- Identify/document process improvement opportunities (e.g., optimization, increased standardization).
- Collaborate with other oversight roles in other TAs for uniformity and consistency.
Basic Qualifications
- Bachelor’s degree and 10+ years of relevant experience; OR
- Master’s degree and 8+ years of relevant experience; OR
- PhD and 2+ years of relevant experience.
Qualifications (Required/Preferred)
- 5+ years as a data scientist or data analyst generating analysis deliverables for observational research.
- Preferred: MS or more advanced degree in Computer Science, Data Science, Biostatistics, or Epidemiology (or equivalent). Required: BS degree in one of these fields (or equivalent).
- Hands-on experience with primary data and real-world data sources using multiple programming tools (e.g., SAS, R) in GxP-compliant environments.
- Demonstrated experience leading/managing programmers and data analysts; balance priorities and timelines in a matrixed environment.
- Proven ability to review programs and analysis outputs for quality, completeness, and best practices.
- Ability to communicate scope/requirements/expectations/standards for time-critical deliverables and to communicate/interpret analysis results.
- Strong data-driven problem-solving and cross-functional collaboration (program, study, functional teams, vendor resources).
- Strong written and verbal communication skills.
- Preferred: Understanding of the RWE regulatory landscape.
- Preferred: Experience with international datasets and/or Common Data Models (e.g., OMOP).
People Leader Accountabilities
- Create Inclusion.
- Develop Talent (coach employees; ensure feedback/insight for growth and performance).
- Empower Teams (align goals/purpose/objectives; remove barriers; connect to broader ecosystem).
Benefits
- Salary range: $165,495.00 - $214,170.00.
- Discretionary annual bonus and discretionary stock-based long-term incentives (eligibility varies by role).
- Paid time off.
- Benefits include company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.