Principal Biostatistician – Vaccines

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors. • Work with client statistical team, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project. • Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses. • Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities. • Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

🎯 Requirements

• MS or PhD in statistics, biostatistics, or related fields with relevant industry working experience. • 2+ years experience working in clinical trial setting. • Proficient with SAS. R is nice to have. • Have experience in authoring and reviewing SAP/TLF shells. • Familiar with CDISC standards. Have experience in reviewing SDTM/ADaM specs. • Have experience in programming and validating SDTM/ADaM/TLFs. • Experience in submission is a plus • Experience with Vaccines studies is preferred. • Strong communication, both verbal and written.

🏖️ Benefits

• Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support.