Sr. Clinical Data Scientist

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

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.

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.

This is the pay for this position

Pay Transparency $148,000—$188,000 USD

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.

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