Associate Director, Real-World Data (RWD) Programmer ( Medical Affairs)
Associate Director, Real-World Data (RWD) Programmer ( Medical Affairs)
United States - California - Foster CityUnited Kingdom - UxbridgeUnited States - District of Columbia - WashingtonIreland - DublinUnited States - New Jersey - Morris PlainsUnited States - North Carolina - RaleighUnited Kingdom - CambridgeUnited States - Washington - Seattle
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
*** Position may be based onsite at the following locations: Foster City, CA, Morris Plains, NJ, Seattle WA, Washington DC, Raleigh, NC, Cambridge, UK, Stockley Park, UK and Dublin, Ireland.
Real world evidence (RWE) has become a vital complement to the traditional clinical trial in the demonstration of the value and safety of new medicines. Recognizing its importance, Gilead has established a core RWE Analytics group within the Clinical Data Sciences (CDS) - RWE Organization to support the use of RWE across the discovery, development, and lifecycle of our medicines. Members of this group will be fully embedded alongside their Clinical, Medical Affairs Research (MAR), and Global Value & Access (GV&A) colleagues, helping to develop and execute their RWE strategies. As a member of the core RWE Analytics group, individuals will have access to real-world databases in-licensed across Gilead and Kite and act as the stewards of Gilead's best practices, standards, and methodologies underlying the use of real-world data (RWD).
As an member of the CDS-RWE Analytics group, the RWD Programmer reports directly Head of RWE Analytics and is responsible for the design and conduct of statistical analyses of RWD to assess the value of Gilead therapies and perform data visualization and QCs TFLs to communicate results to internal stakeholders in Medical Affairs. The RWD Programmer will align with the MAR Therapeutic Area (TA)-aligned Lead to conduct timely, relevant and rigorous analysis of RWD to address critical research questions, as well as collaborate with CDS to develop, refine, and scale data management and analytic procedures, systems, workflows, best practices, and other issues.
- Develop and QC TFLs for protocols/reports/manuscripts from RWE research conducted to assess the value of Gilead therapies using RWD (e.g. claims and EHR).
- QC programming for descriptive and complex studies using RWD.
- Conduct analyses and develop specifications for descriptive and complex statistics in studies using RWD.
- Write the statistical analysis plan (SAP) for descriptive and complex studies using RWD, including from internal Gilead-sponsored prospective cohort studies, claims, charge master and EHR in collaboration with MAR TA lead
- Understand methods and programming to support Comparative Effectiveness Research (CER) analyses, as well as analyses of patient-reported outcomes (PRO) or other patient outcome data
- Develop and QC TFLs for protocols/reports/manuscripts from RWE research conducted to assess the value of Gilead therapies using RWD (e.g. claims and EHR)
- Work with MAR researchers to generate code lists for new measures in RWD
Knowledge, Skills and Experience
- Master's degree (e.g. MA, MSc, MPH) in Biostatistics, Epidemiology or related discipline, such as Outcomes Research from an accredited institution, with a minimum of eight (8) years of relevant, post-graduation experience.
- Doctoral level training with a minimum of two (2) years of relevant experience is preferred. Direct experience in lieu of academic training is acceptable.
- Knowledge of real-world data and experience in observational research study design, execution and communication.
- Strong track record of analysis of a broad range of RWD.
- Formal training in Programming and demonstrated proficiency in statistical analysis programs commonly used in life sciences (e.g. SAS, R).
- Understanding of epidemiology or outcomes research and the application of retrospective or prospective studies to generate value evidence.
- Ability to effectively communicate statistical methodology and analysis results.
- Ability to work effectively in a constantly changing, diverse, and matrix environment.
- Knowledge of US secondary data sources required; additional experience with international data sources is preferred.
- Knowledge and experience in qualitative analysis and data sets (e.g., free-text natural language processing, survey data) is preferred.
The Gilead Difference
Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. But it's just what we do that gives us an edge, it's how we do it. We expect everyone at Gilead to lead by example, guided by our core values:
- Integrity - Doing What's Right
- Inclusion - Encouraging Diversity
- Teamwork - Working Together
- Accountability - Taking Personal Responsibility
- Excellence - Being Your Best
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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@example.com for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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.
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