Sponsor: Rubicon Genomics
Recording Date: 2/19/2014
Recording Time: 1 hour
The successful Senior Biostatistician candidate will be responsible for collaborating with management on statistical strategy and providing statistical support to the project and study teams. Will serve as the primary biostatistician on one or more studies. Will participates in the development of study designs and protocols. Will reviews CRFs, programming plans, and data management plans including edit checks. Will develop statistical analysis plans and analysis file specifications, performs statistical analyses, interprets statistical results, and collaborates on the preparation of clinical study reports and integrated summaries for submissions. Oversees the works of CROs that are performing any of the above listed tasks.
• Participate in study design and protocol development. Ensure that study designs are consistent with study objectives and are optimal within study constraints. Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timing of various scenarios. Propose methods for statistical analysis and write the statistical section of study protocols.
• Review and consult on CRF design and database edit checks. Review programming plans.
• Prepare randomization schedules.
• Prepare statistical analysis plans, specifications for analysis files, and table shells. Ensure that tables, listings, and graphs address the objectives of the study.
• Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary. Oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data.
• Lead the study and/or project teams in the review and discussion of analysis plans.
• Interpret statistical results and present study findings to the study teams, senior management, and in various external forums.
• MS or PhD in Statistics, Biostatistics, or equivalent.
• 6+ years of Biostatistics experience in a drug-development environment.
• Excellent communication skills.
• Prior experience interacting with health authorities in the United States and/or the EU.
• Prior experience with IND/BLA/NDA/MAA submissions.
• 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.
• Ability to manage multiple and diverse issues.
• Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel.
• 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
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 a Senior Biostatistician to join its’ dynamic team.