Principal Clinical Data Reviewer/Scientist
Biogen
June 27, 2026
Remote friendly (Triangle, NC)
United States
Clinical Research and Development
What You’ll Do
- Lead clinical and scientific data review activities across assigned clinical studies to ensure data accuracy, consistency, and alignment with protocol expectations and therapeutic objectives.
- Identify insights, trends, and risks via comprehensive data analysis to enable early detection of data quality issues and safety signals.
- Design, test, and refine clinical data review tools (listings, reports, visualizations) for data exploration, signal detection, and discrepancy management.
- Collaborate with Clinical Development, Biostatistics, Pharmacovigilance, and Study Operations to drive data-driven decision-making and ensure high-quality trial execution.
- Manage timelines and deliverables with a focus on quality, efficiency, and proactive communication.
- Support risk management by identifying, documenting, and mitigating study-level data risks.
- Support strategic process innovation and continuous improvement within Data Management.
- Use metrics and analytics to monitor data trends, assess study health, and improve review strategies.
Required Skills
- 5+ years in Clinical Operations/Clinical Scientific role, or DM in industry/academia with strong scientific knowledge in at least one therapeutic area.
- Robust experience with Medidata Rave and data review tools (eClinical Elluminate, J-Review, Business Objects).
- Strong analytical and communication skills; attention to detail; ability to manage competing priorities.
- Audit/inspection support experience; deep understanding of drug development and biopharmaceutical industry.
- Technical skills including Microsoft Excel; fluent English.
- Hands-on review of eCRF data and external/integrated clinical datasets.
- Ability to identify trends, signals, outliers, and risk indicators using listings/visualizations/analytics.
- CDISC (SDTM, ADaM) and familiarity with clinical analytic/visualization tools.
- Knowledge of GCP and ICH E6(R2)/E6(R3) and data quality best practices.
Education/Preferred
- Bachelor’s in life/health sciences, pharmacy, nursing, data science or related; MS/PharmD/PhD strongly preferred.
- Experience implementing consistent data review processes; coordinate timelines/deliverables across studies.
- Ability to assess and mitigate vendor performance/quality issues.
Benefits
- Medical, Dental, Vision, & Life insurance; fitness reimbursement; short- and long-term disability; paid vacation and end-of-year shutdown; paid holidays and personal significance days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year).
Base compensation range: $116,000.00–$155,000.00
- Lead clinical and scientific data review activities across assigned clinical studies to ensure data accuracy, consistency, and alignment with protocol expectations and therapeutic objectives.
- Identify insights, trends, and risks via comprehensive data analysis to enable early detection of data quality issues and safety signals.
- Design, test, and refine clinical data review tools (listings, reports, visualizations) for data exploration, signal detection, and discrepancy management.
- Collaborate with Clinical Development, Biostatistics, Pharmacovigilance, and Study Operations to drive data-driven decision-making and ensure high-quality trial execution.
- Manage timelines and deliverables with a focus on quality, efficiency, and proactive communication.
- Support risk management by identifying, documenting, and mitigating study-level data risks.
- Support strategic process innovation and continuous improvement within Data Management.
- Use metrics and analytics to monitor data trends, assess study health, and improve review strategies.
Required Skills
- 5+ years in Clinical Operations/Clinical Scientific role, or DM in industry/academia with strong scientific knowledge in at least one therapeutic area.
- Robust experience with Medidata Rave and data review tools (eClinical Elluminate, J-Review, Business Objects).
- Strong analytical and communication skills; attention to detail; ability to manage competing priorities.
- Audit/inspection support experience; deep understanding of drug development and biopharmaceutical industry.
- Technical skills including Microsoft Excel; fluent English.
- Hands-on review of eCRF data and external/integrated clinical datasets.
- Ability to identify trends, signals, outliers, and risk indicators using listings/visualizations/analytics.
- CDISC (SDTM, ADaM) and familiarity with clinical analytic/visualization tools.
- Knowledge of GCP and ICH E6(R2)/E6(R3) and data quality best practices.
Education/Preferred
- Bachelor’s in life/health sciences, pharmacy, nursing, data science or related; MS/PharmD/PhD strongly preferred.
- Experience implementing consistent data review processes; coordinate timelines/deliverables across studies.
- Ability to assess and mitigate vendor performance/quality issues.
Benefits
- Medical, Dental, Vision, & Life insurance; fitness reimbursement; short- and long-term disability; paid vacation and end-of-year shutdown; paid holidays and personal significance days; sick time; paid maternity/parental leave; 401(k) match; employee stock purchase plan; tuition reimbursement (up to $10,000/year).
Base compensation range: $116,000.00–$155,000.00