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Biostatistics Consultant

Ardea Biosciences, Inc.

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Location: San Diego, CA Posted Date: 5/1/2013 Position Type: Consultant, Contract Job Code: 233 Required Education: Masters Degree Areas of Expertise Desired: Biostatistics

Description

Ardea Biosciences, a wholly owned subsidiary of AstraZeneca, is headquartered in San Diego, CA.  We are a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases.  

Ardea is searching for a Biostatistics Consultant to join the team.

Responsible for providing input to statistical analysis plans, and executing on biostatistics aspects of the clinical studies and submissions.

Primary Duties and Responsibilities

Execute the statistical analysis plans (SAP) in support of clinical development programs, phase 1-3 and through NDA, with a primary emphasis in support of our phase 2 and 3 studies
Prepare 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.
May interface with biostatistics resources, primarily CRO, timelines, milestones, and finances in relation to CRO management.
Serve as a biostatistics expert for research, design, analysis, reporting, and presentation of sophisticated statistical analysis and methods for phase 1-3 clinical studies and for nonclinical studies; includes conducting power calculations.
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.
8+ years of Biostatistics experience in a drug-development environment, with phase 2 and 3 experience strongly preferred.
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.

Apply online today at: www.ardeabio.com/careers
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