Associate Director, Analysis Oversight Lead RWE Safety: Inflammation

Gilead Sciences•Parsippany, NJ

About The Position

The Real-World Evidence (RWE) function is part of the Clinical Data Science (CDS) department within the Development organization and aims to unlock the power of real-world evidence to help transform health innovations into life-changing medicines for patients. CDS-RWE conducts observational research and generates analysis results to inform decisions throughout the product lifecycle across research, development, post-approval, and commercialization. Observational research is conducted on data collected from individuals assessed for biomedical, health and other outcomes, and includes observational studies and observational analyses. Source data to generate the analysis results may be based on primary data collection, secondary data use, or both. These analysis results, generated using a rigorous process, provide insights and evidence for internal (e.g., program, safety) and external (e.g., regulators, healthcare providers) stakeholders. Position Summary: The Associate Director, Analysis Oversight Lead RWE Safety: Inflammation position is responsible for the oversight of timeliness and quality of safety programming and analysis deliverable supporting the CDS-RWE Inflammation therapeutic area (TA). This role reports to the CDS-RWE Safety Epidemiologist Lead and partners with CDS-RWE scientific leads and Patient Safety stakeholders to translate safety analysis requirements into high-quality, compliant programming and analysis deliverables. Serving as the primary point of contact for analysis vendors and service vendors, this role is responsible for planning, execution, and quality acceptance of safety analysis deliverables. The position requires demonstrated experience in managing complex analytical workflows to generate analysis results in a GxP compliant programming environment to meet time-critical deadlines.

Requirements

Bachelor's degree and 10+ years of relevant experience; OR Masters' degree and 8+ years of relevant experience; OR PhD and 2+ years of relevant experience
5+ years of experience as a data scientist or data analyst in generating analysis deliverables for observational research
MS or more advanced degree in Computer Science, Data Science, Biostatistics, Epidemiology or equivalent preferred, BS degree in Computer Science, Data Science, Biostatistics, Epidemiology or equivalent required
Hands-on training and experience working with both primary data as well as real world data sources using multiple programming tools (e.g., SAS, R) in GxP compliant systems environment
Demonstrated experience in leading and managing work of programmers and data analysts to balance priorities and timelines in a matrixed environment
Proven ability to review programs and analysis outputs for quality, completeness and best practices
Ability to clearly communicate the scope, requirements, expectations and standards for generating time-critical analysis deliverables
Ability to communicate and interpret analysis results
Strong problem-solving skills using data driven approaches
Demonstrated ability to collaborate cross-functionally with program, study and functional teams, and vendor resources
Strong written and verbal communication skills

Nice To Haves

Understanding of the RWE regulatory landscape preferred
Experience in working with international data sets and/or Common Data Models (e.g., OMOP) preferred

Responsibilities

Responsible for tracking, prioritization and delivery of programming and analysis deliverables to meet pharmacoepidemiology and safety requirements across the TA portfolio
Partner with the CDS-RWE Safety Epidemiology Lead to ensure programming and analysis deliverables are generated using a compliant and traceable process
Responsible for vendor performance management and escalation of risks impacting compliance or timeliness of analysis deliverables
Responsible for the vendor oversight plans, performance and quality checks, for programming, analysis and other deliverables per the vendor oversight process
Own end-to-end oversight of analysis deliverables, ensuring timely, high-quality completion aligned to TA priorities, with proactive risk identification and mitigation
Partner with the CDS-RWE scientific leads and Patient Safety stakeholders to monitor translation of requirements into analysis specifications and deliverables by vendors or service providers
Monitor and review the quality of programming and analysis deliverables e.g., specifications, programs, cohorts, feasibility results, analysis results, publications, abstracts, and other outputs
Monitor vendor and service provider processes to ensure compliance with quality and regulatory requirements
Ensure locking or archiving of programming and analysis deliverables and outputs, as appropriate
Monitor utilization and coordinate assignment of analyses to vendors or service providers to meet quality and timeline priorities
Serve as an escalation point to resolve quality, scope and timeliness issues with vendors and service providers
Maintain regular communication with vendors and service providers to deliver on agreed upon priorities and milestones
Ensure onboarding of vendors and service providers to data analysis tools, programming environments, and access to observational data
Identify and document areas to improve efficiency, e.g., process optimization, increased standardization, etc.
Collaborate with other oversight roles in other TAs for uniformity and consistency

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume