Senior Biostatistician
Alcock & McFadden - San Diego, CA

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Ardea Biosciences/Astra Zeneca NOW HIRING...Senior Biostatistician

Ardea Biosciences, Inc. a wholly owned subsidiary of Astra Zeneca based in San Diego is a Biotechnology Company focused on he development of small molecule herapeutics for he treatment of serious diseases. Ardea is seeking a Senior Biostatistician to join its' dynamic team.
he succe sful Senior Biostatistician candidate will be responsible for collaborating wi h management on statistical strategy and providing statistical support to he project and study teams. Will serve as he primary biostatistician on one or more studies. Will participates in he 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 he preparation of clinical study reports and integrated summaries for submi sions. Oversees he works of CROs hat are performing any of he above listed tasks.

Responsibilities include:
  • Participate in study design and protocol development. Ensure hat study designs are consistent wi h study objectives and are optimal wi hin study constraints. Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate he costs and timing of various scenarios. Propose me hods for statistical analysis and write he 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 hat tables, listings, and graphs addre s he objectives of he study.
  • Perform statistical analyses of clinical data using SAS and o her statistical software packages as nece sary. Oversee he work of internal programmers and/or CROs hat are performing statistical analyses of clinical data.
  • Lead he study and/or project teams in he review and discu sion of analysis plans.
  • Interpret statistical results and present study findings to he 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 wi h heal h au horities in he United States and/or he EU.
  • Prior experience wi h IND/BLA/NDA/MAA submi sions.
  • Experience or training wi h a range of skills including SAS programming and o her relevant software applications, statistical me hodology and heories, and analysis.
  • Experience wi hin a team environment, have strong presentation skills, collaborative skills, negotiation skills and demonstrate self-motivation.
  • Ability to manage multiple and diverse i sues.
  • Excellent computer skills in he 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

Alcock & McFadden - 12 months ago - save job - copy to clipboard