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Sr. Principal Biostatistician
Durham, NC 22703 United States
Pearl Therapeutics, a wholly-owned subsidiary of AstraZeneca, is a growing, dynamic company focused on developing inhalation combination therapies for the treatment of highly prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma. Pearl is seeking to hire individuals that bring energy and passion to deliver the medicines that provide patients and healthcare provider’s therapies to achieve better clinical outcomes.
Purpose: The Manager of Biostatistics is responsible for statistical, statistical programming, and data management tasks to support the clinical development of Pearl Therapeutics projects.
Duties and Responsibilities:
• Review statistical analysis plans and mock table specifications prepared by CROs.
• Review statistical output for accuracy/completeness and prepare slide presentations of the results
• Propose potential clinical study designs and compare their efficiency through analytical approaches or simulation
• Perform ad hoc and exploratory data analyses.
• Review and provide input for eCRFs, data management plans, data validation specifications (edit checks), and data transfer specifications
• Provide statistical input for the preparation of study protocols, final study reports, integrated reports, and other required documents.
• Support preparation of manuscripts.
• Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.
• PhD/MS in statistics, biostatistics, or a related field.
• Experience in clinical drug development: 5 years with PhD and 8 years with MS.
• Experience in the development of medications for the respiratory therapeutic area highly desirable
• Excellent planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel.
• Demonstrated skill in the planning, analysis, and reporting of clinical trials.
• Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies.
• Excellent SAS skills including report generation. Willingness to be a hands-on contributor.
• Sound decision-making skills and demonstrated ability to exercise good judgment.
• Advanced knowledge of MS Office products (Word, Excel, PowerPoint).
• Excellent interpersonal, communication, writing and organizational skills.
• Demonstrated ability to work in a team environment with medical personnel, clinical monitors, statisticians, data managers, programmers, and medical writers.
• Demonstrated ability to collaborate successfully and considerable organizational awareness (e.g., inter-relationship of departments, business priorities), including significant experience working cross-functionally and in global teams.
• Proficiency with Microsoft Office Suite products
Reports to: Director Biostatistics
Primary Location: Morristown, NJ
Status: Full-time, regular – Exempt
North Carolina Biotechnology Center