Associate Director, Analysis Oversight Lead RWE Safety: Inflammation

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

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.

Key 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

Basic Qualifications

• 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

Qualifications: 

• 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 

• Understanding of the RWE regulatory landscape preferred 

• Experience in working with international data sets and/or Common Data Models (e.g., OMOP) preferred 

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

 

The salary range for this position is: $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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