Clinical Research

• Join our Clinical Surveillance & Training (CST) team as a Clinical Scientist
• Lead Rater Training Excellence: Design and deliver scientifically grounded rater training programs to ensure consistent, high-quality endpoint assessment and reduce variability across sites
• Drive Patient Eligibility Quality: Perform comprehensive eligibility reviews, providing a second level of scientific oversight to confirm appropriate patient selection and minimize protocol deviations and safety risks
• Deliver Data-Driven Insights: Analyze clinical and endpoint data to identify trends, variability, and potential risks—translating findings into actionable insights that improve study execution
• Shape Protocol Strategy: Partner with sponsors and study teams to review protocols and provide expert guidance on endpoint strategy, scale selection, and study design feasibility
• Act as a Scientific Leader: Collaborate cross-functionally with clinical operations, medical, and sponsor teams to proactively identify risks and deliver solutions that protect study integrity

Clinical Scientist – Clinical Surveillance & Training, Clinical Psychologist/Neuropsychologist

• Develop medical plans and coordinates with Medical Directors
• Perform medical reviews of data listings
• Author and review medical data queries
• Manage project scope and quality of deliverables
• Collaborate with study team members to identify risks

Clinical Scientist – Immunology, Ulcerative Colitis, Crohn’s Disease, Rheumatology

• Serves as a statistical department resource, mentors biostatisticians on job skills, oversees or develop training plans or materials for Biostatistics associates.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures.
• Responsible for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report.
• Reviews SAS annotated case report forms (CRFs), SAS database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work.

Principal Biostatistician, RWE – PASS Experience

• Support Safety Analytics with ADaM /TFL standard development for Hypersensitivity and Injection/Infusion Site Reaction deliverables
• Support Safety Analytics and the study team on the delivery of Hepatic Patient Profile display
• Provide ADaM /TFL/interactive package review support for the Safety Analytics team supported portfolio deliveries
• Interrogating root cause of issues identified during ADaM /TFL/Interactive package review

Senior Clinical Pharmacology/Biopharmaceutical Biostatistician

• Lead end-to-end clinical trial execution, ensuring delivery against timelines, quality standards, and budget
• Provide operational oversight of site management and monitoring activities, including on-site and centralized monitoring
• Identify, assess, and proactively mitigate clinical and operational risks using a risk-based management approach (RACT)
• Serve as the primary escalation point for CRAs, investigative sites, and cross-functional stakeholders
• Partner closely with Study Start-Up, Data Management, Biostatistics, Safety, and Patient Recruitment teams to drive milestone achievement
• Leverage integrated systems and data (CTMS, EDC, ePRO, TMF, dashboards) to monitor performance, trends, and risk indicators
• Ensure ongoing inspection readiness and compliance with ICH-GCP, SOPs, and global regulatory requirements
• Lead study-specific training and foster alignment across the clinical trial team
• Review metrics and operational data to anticipate challenges and implement timely solutions
• Mentor and support CRAs, contributing to a culture of accountability, continuous improvement, and collaboration

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Clinical Scientist – Clinical Surveillance & Training, Clinical Psychologist/Neuropsychologist

Clinical Scientist – Immunology, Ulcerative Colitis, Crohn’s Disease, Rheumatology

Principal Biostatistician, RWE – PASS Experience

Senior Clinical Pharmacology/Biopharmaceutical Biostatistician

Clinical Trial Manager – US