Principal Clinical Data Reviewer/Scientist

Biogen•Research Triangle Park, NC

3d•$116,000 - $155,000

About The Position

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. What You’ll Do 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. Who You Are You have a strong passion for scientific data excellence and clinical research quality. You possess strong analytical skills with the ability to translate complex data into actionable insights. You have a strong collaborative mindset with the ability to work effectively across multifunctional teams. You are committed to maintaining the highest quality execution and continuous improvement in data review practices.

Requirements

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.

Nice To Haves

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.

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.

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