Oracle Life Sciences is seeking a qualified health outcomes researcher with a Master’s or PhD to join our Real World Evidence Tobacco Harm Reduction team. In this role you will have the opportunity to lead the design, analysis, and reporting of regulatory studies (e.g., studies which need to meet the scientific rigor for FDA CTP submissions) and provide research consultation to both internal and external clients. This role requires a strategic thinker with strong research, writing, and communication skills.
Oracle Life Sciences is looking for a strategic leader responsible for designing, executing, and interpreting behavioral research to support regulatory submissions, including PMTAs. The ideal candidate brings deep expertise in behavioral science, regulatory strategy, and cross-functional collaboration to ensure all data meets FDA requirements.
As Sr. Research Scientist in RWE Tobacco Harm Reduction, you will:
- Be the Principal Investigator, lead the design of behavioral studies (e.g., Actual Use, PMSS, TPPI) including writing research proposals, collaborating on protocol and statistical analysis plan (SAP) development, overseeing data analysis, providing analytical interpretation, writing reports, abstracts, posters, and manuscripts.
- Successfully lead engagements to ensure client satisfaction and ensure deliverables are sent on time and are of rigorous scientific quality.
- Monitor evolving FDA guidance and behavioral science methodologies to inform regulatory strategy and study design.
- Present at professional conferences.
- Be available for travel to support of all of the above responsibilities.
To succeed, you will need:
- Minimum a MPH or Master’s with 5+ years of industry experience or PhD with 5 years of independent research experience - any advanced degree in epidemiology, public health, or related discipline
- Must have experience in survey design and quantitative methods
- Strong scientific writing and presentation skills for client engagement.
- Knowledge of and experience working with statistics including regression techniques (OLS, logistic regression, generalized linear models), mixed models (e.g., survival and longitudinal analysis), non-parametric approaches, and data reduction techniques (e.g., factor analysis, SEM)
- Must have a strong publication history with multiple peer-reviewed manuscripts
- Knowledge of CDISC SDTM and ADaM standards
- Experience with PMTA-specific studies preferred, such as Actual Use studies (AUS), Tobacco Product Perception and Intention (TPPI) or Post Market Surveillance studies (PMSS)
- Excellent oral and written communication skills
- Ability to multitask several projects in a fast-paced environment
- Proficiency in MS PowerPoint, MS Excel, MS Word. R or SAS a plus.
Disclaimer:
Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.
Range and benefit information provided in this posting are specific to the stated locations only
US: Hiring Range in USD from: $79,100 to $158,200 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
- Medical, dental, and vision insurance, including expert medical opinion
- Short term disability and long term disability
- Life insurance and AD&D
- Supplemental life insurance (Employee/Spouse/Child)
- Health care and dependent care Flexible Spending Accounts
- Pre-tax commuter and parking benefits
- 401(k) Savings and Investment Plan with company match
- Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
- 11 paid holidays
- Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
- Paid parental leave
- Adoption assistance
- Employee Stock Purchase Plan
- Financial planning and group legal
- Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC3