Principal Clinical Data ReviewerScientist
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Job Location:
Durham County, NC - USA
Monthly Salary:
$ 116000 - 155000
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 Youll 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 toolsincluding listings reports and visualizationsto support robust data exploration signal detection and discrepancy management.
- Collaborate closely with crossfunctional teams including Clinical Development Biostatistics Pharmacovigilance and Study Operations to drive datadriven decisionmaking 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 studylevel 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.
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)
- Handson 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 problemsolving skills with a continuous improvement mindset and enthusiasm for scientific data excellence.
Education Requirements/Preferred Skills
- Bachelors 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
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.
Additional Information
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 $10000 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 onto 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.
Required Experience:
Staff IC
Key Skills
- Machine Learning
- Python
- Data Science
- AI
- R
- Research Experience
- Sensors
- Drug Discovery
- Research & Development
- Natural Language Processing
- Data Analysis Skills
- Toxicology Experience
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
