Principal/Senior Clinical Data Scientist

Role overview A senior or principal-level clinical scientist role leading the clinical science function across oncology, rare disease, and autoimmune clinical development programs, from study start-up through database lock. The work centers on bringing scientific and indication-specific judgment to clinical trial data review, partnering with data management, biostatistics, medical monitoring, and other functional teams to keep participant data clean, protocol-compliant, and clinically meaningful.

Responsibilities - Serve as the functional lead for clinical science on assigned studies from start-up through database lock, delivering against scope, timeline, and budget. - Perform holistic and aggregate participant data review, applying clinical and scientific judgment to query management and clinically relevant data cleaning rather than relying only on programmed exclusion listings. - Act as the clinical and scientific subject matter expert on study teams, guiding eCRF design, data capture requirements, edit checks, completion guidelines, EDC user acceptance testing, and ongoing review. - Support Risk-Based Quality Management by identifying and addressing study risks, trends, and issues, and partnering with cross-functional teams on risk review. - Collaborate with medical monitoring on participant data review findings and provide protocol-level scientific and operational input. - Maintain clinical science project plans, guidelines, trackers, and programming specifications, and ensure applicable eTMF documentation is accurate. - Contribute to study-level strategy, data review process improvements, and business development activities such as bid defense meetings, and review tables, figures, listings, or clinical study reports as needed.

Requirements - Bachelor's degree or equivalent in a science or health-related discipline, with strong medical terminology. - Minimum of 8 years of clinical research experience, or demonstrated competencies for the level. - At least 3 years of recent oncology experience (within the past 1.5 years); familiarity with criteria such as CTCAE, ASTCT, RECIST 1.1, Lugano, and ICANS. - At least 1 year of leadership experience, with a track record of mentoring and developing junior team members. - High proficiency with Microsoft Office tools and strong written and verbal communication, including presentation of data, trends, and escalations. - Working knowledge of FDA and ICH-GCP guidelines, relevant SOPs, and the broader clinical trial process, with the ability to operate independently in a global, cross-functional environment and escalate appropriately.

Nice to have - A medical-related degree such as RN, OCN, PharmD, or RPh. - Experience with Electronic Data Capture systems, database build, on-site clinical work, monitoring, or data visualization platforms.

Benefits and work setup - Up to roughly 25% domestic and international travel, including overnight stays. - Candidates must be legally authorized to work in the country of employment without employer sponsorship.