Location: On-Site 4 days per week at our Menlo Park CA office
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:
- Masters or Bachelors 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
The pay range for this role is $170000 to $190000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.
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 Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Senior Manager