Job Description

Join Oracle Life Sciences as a health outcomes researcher with a Master's or PhD, and become an integral part of our Real World Evidence Tobacco Harm Reduction team. In this exciting role, you will lead the design, analysis, and reporting of high-impact regulatory studies that support FDA CTP submissions. We are looking for a strategic thinker who excels in research direction, writing, and communication, and can bring innovative ideas to the team.

As a Senior Research Scientist, you will have the unique opportunity to shape behavioral research that aids in regulatory submissions, including PMTAs. The ideal candidate will possess deep expertise in behavioral science and regulatory strategy, while exhibiting strong collaboration skills to ensure that all data meets rigorous FDA standards.

Key Responsibilities

• Lead the design of behavioral studies such as Actual Use, PMSS, and TPPI, acting as the Principal Investigator while overseeing the development of research proposals, protocols, and statistical analysis plans (SAP).
• Ensure client engagement and satisfaction by delivering high-quality, timely project outputs.
• Stay updated on evolving FDA guidelines and behavioral science methodologies to inform regulatory approaches and study designs.
• Present your findings and insights at professional conferences, enhancing your visibility in the field.
• Travel as needed to support the responsibilities above.

To Succeed, You Will Need:

• A minimum of a MPH or Master's degree with 5+ years of related experience, or a PhD with at least 5 years of independent research experience in epidemiology, public health, or a related discipline.
• Experience in survey design and quantitative research methods is essential.
• Strong scientific writing and presentation skills for effective client communication.
• Proficient knowledge and experience with various statistical methods, including regression techniques, mixed models, non-parametric approaches, and data reduction techniques.
• A robust publication record with multiple peer-reviewed manuscripts.
• Familiarity with CDISC SDTM and ADaM standards is a plus.
• Preferred experience with PMTA-specific studies, including Actual Use studies, Tobacco Product Perception and Intention (TPPI), or Post Market Surveillance (PMSS) studies.
• Excellent oral and written communication abilities.
• A strong capacity for multitasking in a dynamic and fast-paced work environment.
• Proficiency in MS PowerPoint, MS Excel, MS Word. Experience with R or SAS is a bonus.

Disclaimer

Compliance with applicable immunization and occupational health mandates may be required for certain roles.

Salary Range and Benefits:

The hiring range is between $79,100 and $158,200 per annum, with potential eligibility for bonuses and equity. Oracle offers a comprehensive benefits package, including medical, dental, and vision insurance, short and long-term disability coverage, retirement savings with a company match, flexible vacation, paid holidays, and more.

Join us at Oracle, where your skills can drive industry innovation and contribute to life-saving healthcare solutions.