Principal Clinical Data Reviewer/Scientist

Responsibilities

• Lead clinical and scientific data review activities across assigned clinical studies, ensuring data accuracy, consistency, and alignment with protocol expectations and therapeutic objectives.
• Identify insights, trends, and risks through comprehensive data analysis and interpretation, enabling early detection of data quality issues and safety signals.
• Design, test, and refine clinical data review tools-including listings, reports, and visualizations-to support robust data exploration, signal detection, and discrepancy management.
• Collaborate closely with cross‑functional teams, including 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 strong commitment to quality, efficiency, and proactive communication.
• Contribute to risk management by identifying, documenting, and supporting mitigation of study‑level data risks.
• Support strategic initiatives within and beyond the Data Management organization, bringing scientific and operational insight to process innovation and continuous improvement.
• Leverage metrics and analytics to monitor data trends, assess study health, and enhance data review strategies.

Requirements

• Required Skills
• 5+ years in a Clinical Operations/Clinical Scientific role, or in DM in industry or Academia with strong scientific knowledge in at least one therapeutic area within Biogen portfolio.
• Robust experience with Medidata Rave and use of Data Review tools such as eClinical Elluminate, J-Review, or Business Objects required
• High attention to detail including proven ability to manage multiple, competing priorities
• Experience supporting audits/inspections
• Excellent written and oral communication skills
• Ability to work under pressure demonstrating agility through effective and innovative team leadership
• Deep understanding of drug development and biopharmaceutical industry required
• Strong technical skills, including experience working with using Microsoft Excel functionality
• Fluent English (oral and written)
• Hands‑on experience reviewing eCRF data, external data sources (e.g., labs, imaging, biomarkers, digital health), and integrated clinical datasets.
• Demonstrated ability to identify data trends, signals, outliers, and risk indicators using listings, visualizations, metrics, and analytics tools.
• Experience with CDISC standards (SDTM, ADaM) and familiarity with clinical analytic tools (visualization platforms).
• Strong knowledge of GCP, ICH E6(R2)/E6(R3), regulatory expectations, and industry data quality best practices.
• Demonstrated problem‑solving skills with a continuous improvement mindset and enthusiasm for scientific data excellence.
• Education Requirements/Preferred Skills
• Bachelor's degree in life sciences, health sciences, pharmacy, nursing, data science, or related discipline; advanced degree (MS, PharmD, PhD) strongly preferred.
• Experience with implementing consistent clinical and scientific data review processes.
• Ability to highlight and mitigate performance and quality issues with vendors.
• Previous experience in coordinating timelines and data deliverables across multiple studies/programs.
• Why Biogen?
• Job Level: Management
• Additional Information
• The base compensation range for this role is: $116,000.00-$155,000.00
• Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
• Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and reco

Benefits

Additional Information

About This Role As a Principal Clinical Data Reviewer/Scientist, you will play a critical leadership role in ensuring the integrity, scientific rigor, and strategic value of clinical trial data across all phases of development. You will apply deep clinical and scientific expertise to assess data quality, plausibility, and completeness, while proactively identifying trends, signals, and potential risks related to study endpoints and patient safety.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at Biogen? Share your experience