Biogen · 23 hours ago
Principal Clinical Data Reviewer/Scientist
Research Triangle Park, NC
Full-time
Hybrid
Senior Level, Lead/Staff
$116K/yr - $155K/yr
5+ years expBiogen is a mid-sized biotechnology company focused on finding therapies for neurological and rare diseases. The Principal Clinical Data Reviewer/Scientist will lead the review of clinical trial data, ensuring its integrity and scientific rigor while collaborating with cross-functional teams to drive data-driven decision-making.
BiotechnologyHealth CareNeuroscienceTherapeutics
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
Qualification
Required
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
Preferred
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
Benefits
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
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