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Principal Clinical Data Reviewer/Scientist
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.
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.
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.
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.
- 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.
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.
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 recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
