Overview of Role:
Summit is seeking a highly motivated Sr. Clinical Data Scientist to join our growing team. This role will be instrumental in advancing our technology-enabled and data-driven clinical data review and study monitoring strategy through automation, analytics, and cross-functional data support.
The ideal candidate will be proficient in R and/or Python and apply these skills across clinical data domains to enhance processes, increase efficiency, and elevate data quality. A strong focus on workflow optimization, coupled with a passion for implementing technical solutions in a fast-paced pharmaceutical environment, will be essential for success.
Role and Responsibilities:
- Develop clinical study reports, dashboards, and data visualizations using R or Python.
- Partner closely with the Data Management team to implement data-monitoring or reconciliation listings and edit checks that support ongoing data review.
- Collaborate with Clinical Operations to generate study metrics and identify potential site-level risks.
- Communicate requirements clearly with vendors, author and curate specs, and ensure the results delivered by vendors.
- Perform data wrangling and data processing in R/Python to support the summarization and interpretation of clinical trial data.
- Build ETL pipelines in a Windows environment to automate clinical data workflows and streamline clinical programming activities.
- Develop and maintain reusable R packages for data cleaning, transformation, and validation.
- Maintain complete, accurate, and audit-ready documentation and specs for all programming activities.
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 3 years Pharmaceutical/Biotech programming experience.
- Proficiency in R or Python, and experience with data visualization tools (e.g., Shiny, Spotfire, Tableau) and R packages
- Understanding of EDC and clinical trial processes
- Demonstrated ability to collaborate with cross-functional teams and translate non-technical requirements into technical solutions
- The ability to work well under pressure and shift priorities, both as a team leader and as a team member.
- Ability to communicate clearly both oral and written.
Preferred:
- Experience with maintaining data visualization systems
- Experience with Github
- Prior experience in oncology or complex therapeutic areas
- Ability to proactively identify and address project uncertainties to minimize risk.
- Strong problem solving and analytical skills.