Director, Analysis Oversight Lead RWE: Inflammation
Job Description
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 DescriptionThe 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 Director, Analysis Oversight Lead RWE: Inflammation position is responsible for the oversight of timeliness and quality of analysis results supporting the CDS-RWE book of work for the Inflammation therapeutic area (TA). This role reports to the CDS-RWE TA Head and supports the scientific leads in implementing strategies to generate analysis results that deliver on portfolio priorities. Serving as the primary point of contact for study and analysis vendors and service vendors, this role is responsible for planning, execution, and quality acceptance of analysis deliverables. The position requires demonstrated experience in managing complex analytical workflows across multiple programs to generate high-quality analysis results in a GxP compliant programming environment using a broad range of RWD sources.
Director level: Shapes TA-level analysis delivery strategy, drives cross-program prioritization, influences development and implementation of standards and analytical capabilities across CDS-RWE, in addition to execution oversight.
Key Responsibilities:
Responsible for working with the CDS-RWE TA Head to track, prioritize and manage the execution of analysis deliverables across the TA portfolio
Partner with the CDS-RWE TA Head on data strategy and advanced analytical tools and methods to enable the TA portfolio
Responsible for vendor performance management and escalation of risks impacting the TA portfolio
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 to monitor translation of observational research protocols and analysis 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
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
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
Collaborate with Gilead Data Office on awareness and training for licensed observational datasets
Basic Qualifications:
Bachelor's degree and 12+ years of relevant experience; OR
Masters' degree and 10+ years of relevant experience; OR
PhD and 8+ 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 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.
For additional benefits information, visit:
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
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