Principal Clinical Data Reviewer – Scientist

Biogen

Principal Clinical Data Reviewer at Biogen ensuring integrity and quality of clinical trial data across all phases of development. Leading data review activities and collaborating with cross-functional teams for high-quality trial execution.

Posted 6/24/2026full-timeResearch Triangle Park • North Carolina • 🇺🇸 United StatesLead💰 $116,000 - $155,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

data analysisdata reviewclinical data review toolseCRF data reviewCDISC standardsMicrosoft Excelvisualization toolsmetrics and analyticsrisk managementdata quality assessment

Soft Skills

attention to detailcommunication skillsteam leadershipproblem-solvingagility under pressuremulti-taskingcollaborationprocess innovationcontinuous improvementscientific data excellence