On-Site at our Palo Alto, CA Office Mon - Thurs
Overview of Role:
Summit is looking for a highly motivated Sr. Manager/ Principal Clinical Data Scientist to join our growing team. This role will play a critical part in advancing our technology and data-driven clinical data review and monitoring strategy through automation, analytics, and cross-functional data support. The ideal candidate will have deep experience in clinical data programming in a biotech industry, an eye for workflow optimization, and a passion for applying technical solutions to improve data quality and operational efficiency.
Role and Responsibilities:
- Programming and Automation
- Use programming expertise to gain insight into clinical data
- Design and implement automation strategies to streamline clinical data programming workflows
- Develop and maintain reusable code modules and templates for data cleaning, transformation, and validation
- Support development of advanced edit checks, derived datasets, and statistical outputs to support data review
- Collaborate closely with Statistical Programming and Biostatistics to ensure data cleaning efforts are aligned with analysis goals and regulatory submission requirements
- Leverage AI and machine learning tools to enhance data review efficiency and automate tracking of review activities and data quality issues
- Cross-Functional Data Support
- Serve as a design and technical resource to cross-functional teams including Clinical Operations, Clinical Development, Biostatistics, and Safety
- Collaborate with Clinical Data Managers to organize complex data sources and support ongoing reviews and data reconciliations
- Translate functional review needs into scalable data solutions and tools
- Visualization and Dashboard Development
- Design and develop interactive dashboards to visualize key clinical data, metrics, and workflow statuses
- Partner with stakeholders to ensure dashboards meet user needs and enable timely, informed decision-making
- Monitor dashboard performance, iterate on features, and resolve data integration issues
- Leadership and Collaboration
- Foster technical growth within the Clinical Data Science team
- Represent Clinical Data Science in cross-functional working groups and process improvement efforts
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Required:
- Master’s or Bachelor’s degree in Data Science, Biostatistics, Computer Science, Life Sciences, or a related field
- Minimum of 8+ years of experience in clinical data programming or clinical data science within a pharmaceutical, biotech, or CRO environment
- Proficiency in R, SAS, or Python, and experience with data visualization tools (e.g., Shiny, Spotfire, Tableau)
- Strong understanding of clinical data standards (e.g., CDISC, SDTM) and clinical trial processes
- Demonstrated ability to collaborate with cross-functional teams and translate non-technical requirements into technical solutions
Preferred:
- Experience with maintaining data visualization systems
- Experience with Github
- Familiarity with EDC systems (e.g., Medidata Rave) and other external data sources
- Prior experience in oncology or complex therapeutic areas
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.
