Associate Director/Director, Biostatistics

Organization: 
Ardea Biosciences/Astra Zeneca
Job Location: 
San Diego, CA
Job Description: 

The successful Associate Director/Director, Biostatistics candidate will be responsible for developing and directing the statistical strategies, design and analyses for clinical trials in all phases of clinical studies and development compounds. Oversees and directs CRO activities, and serves as the statistical expert accountable for all statistical aspects of clinical studies and submission, including scientific validity, quality, and relevance from a regulatory perspective.

Responsibilities include:
• Lead design, preparation and execution of statistical analysis plans (SAP) in support of clinical development programs, phase 1-3 and through NDA.
• Oversee and direct the execution of the SAP, preparation of the statistical methods and results sections for clinical study reports and overall summaries; this responsibility includes review of protocols and CRFs for soundness of trial design.
• Manage biostatistics resources, primarily CRO, timelines, milestones, and finances in relation to CRO management.
• Represent SAP, method, results, conclusions and inferences to regulatory agencies, health authorities or other external meetings.
• Serve as a primary source of scientific support for the research, design, analysis, reporting, and presentation of sophisticated statistical analysis and methods for phase 1-3 clinical studies and for nonclinical studies.
• Maintain strong knowledge of regulatory guidance including Good Clinical Practice, therapeutic area clinical guidelines, statistical guidelines, quality of life and patient reported outcomes.
• Develop SOPs to ensure compliance with GCPs related to clinical study conduct.
• Collaborates with Clinical, Development Operations, Translational Medicine, Regulatory, and Pharmaceutical Sciences and represents the Biostatistics function on the integrated project teams.

Requirements: 

• MS or PhD in statistics or related discipline.
• 10+ years of Biostatistics experience in a drug-development environment, with at least some experience in a leadership level within a sponsor-company setting.
• Demonstrated experience with FDA/EU health authorities, and must have strong knowledge of regulatory requirements.
• Prior experience taking a drug through to NDA/MAA.
• Experience or training with a range of skills including SAS programming and other relevant software applications, statistical methodology and theories, and analysis.
• Experience within a team environment, have strong presentation skills, collaborative skills, negotiation skills and demonstrate self-motivation.
• Proficiency in strategizing, planning, monitoring and problem solving.
• Adept at outsourcing and managing contract organizations.
• Experience in being a leader contributing to the statistical aspects of clinical protocol design, writing, data interpretation, review and reporting of results for multiple studies of different types for multiple projects is required.
• Ability to manage multiple and diverse issues.
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project.
• Ability to “roll up your sleeves” and individually contribute results to a research and development effort.
• Experience writing technical and management documents, reports and presentations.
Interested parties please apply on-line at: www.ardeabio.com/careers

Contact Information: 

Interested parties please apply on-line at: www.ardeabio.com/careers

About Our Organization: 

Ardea Biosciences, Inc. a wholly owned subsidiary of Astra Zeneca based in San Diego is a Biotechnology Company focused on the development of small molecule therapeutics for the treatment of serious diseases. Ardea is seeking an Associate Director/Director, Biostatistics to join its’ dynamic team.