Senior Principal Scientist, Data Science RWE
About The Position
The Real-world Evidence & Advanced Analytics team within Johnson and Johnson Innovative Medicines is looking for outstanding scientists and leaders. This role involves being a hands-on scientific and technical leader, leading a portfolio of RWE projects, developing best practices, and mentoring team members. The position also focuses on identifying common technical requirements for RWE projects and developing a common suite of tools to accelerate project delivery. The role requires end-to-end expertise in RWE studies, including conceptualizing research questions, data feasibility, study design, analysis, programming, and interpretation. It also involves providing thought leadership and hands-on programming expertise for applying Real-World Data (RWD) methodologies to mitigate biases in external control arm studies, hybrid control studies, and comparative effectiveness analyses. Additionally, the role requires generating actionable insights from post-hoc RCT analyses, observational databases, and literature reviews to support regulatory agency interactions. The scientist will independently create study protocols, statistical analysis plans, and statistical programming deliverables, and partner with Data Science Therapeutic Area scientists to conceptualize, lead, shape, and deliver Real World Evidence.
Requirements
- A Ph.D. degree in epidemiology or biostatistics
- Expert coding skills using R, Python, or SAS
- At least 5 years of relevant experience within biopharma companies, RWE consulting firms, or other relevant healthcare industries
- Extensive hands-on experience with data extraction, cleaning, and analysis, as well as statistical methods to mitigate confounding and selection biases
- Expertise with multiple real-world data sources (EHR, insurance claims, registry data).
- Familiarity with clinical trial data structure
- Excellent interpersonal, communication and presentation skills
Nice To Haves
- Familiarity with drug discovery and the clinical development process
- Subject matter knowledge in oncology, Immunology or Neuroscience
- Experience in regulatory-grade evidence, communicating and responding to agency reviews and comments.
Responsibilities
- Be a hands-on scientific and technical leader, leading a portfolio of RWE projects, developing best practices, and mentoring team members.
- Identify common technical requirements for RWE projects, develop and maintain a common suite of tools that enable RWE data scientists to accelerate project delivery.
- End-to-end expertise in RWE studies including conceptualizing research questions, data feasibility, study design, analysis, programming, and interpretation.
- Provide thought leadership and hands-on programming expertise for developing and applying Real-World Data (“RWD”) methodologies to mitigate observed and unobserved biases in the execution of external control arm studies, hybrid control studies, comparative effectiveness analyses, etc.
- Provide thought leadership and hands-on programming expertise to generate actionable insights from post-hoc RCT analyses, observational databases, and literature reviews to support regulatory agency interactions.
- Independently create study protocols, statistical analysis plans, and statistical programming deliverables including analysis-ready data, tables and figures
- Partner with the Data Science Therapeutic Area scientists to conceptualize, lead, shape and deliver Real World Evidence
Benefits
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- 10 days Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
