Director ( Sr ), Biostatistics

Arena Pharmaceuticals   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 95 days ago

This job is no longer available.

This an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas. 

The Director/Sr of Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.

What you’ll dive into

  • Reviews or authors statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications, generates or reviews study randomization, sample size/power estimations
  • Provides statistically sound scientific methodology experimental design and data analysis input to meet project objectives and FDA (and other regulatory agencies) statistical and data requirements
  • Authors or leads the development and execution of SAP
  • Develops statistical programs to perform pre-specified or ad-hoc analyses and prepare data displays
  • Performs and reports study results of statistical analyses to provide interpretation of data and sound study conclusions
  • Collaborates with the programming and data management, functions to ensure data collection and reporting is done in conformance with ongoing practice and regulatory expectations
  • Provides leadership to the organization, in evaluating alternative or innovative methods of analyzing and interpreting data, evaluates implications for study design

What we expect

  • MS. in Statistics, Biostatistics, or Mathematics; PhD preferred
  • 10+ years of progressive and relevant experience in full-cycle drug development/pharma required; Experience in the commercialization of therapeutics is highly desirable
  • Significant experience selecting/managing biostatistics CROs and vendors
  • Technical knowledge of database structure, relevant statistical software such as SAS®, East®, and R
  • Strong SAS® and R programming background including macro development and program validation
  • Demonstrated experience leading change implementations using FDA/CHMP/ICH guidelines and Regulatory submission of datasets using CDISC, including development of SDTM and ADaM specifications
  • Significant experience using MS Office including Project, Excel, PowerPoint required; Experience with SharePoint highly preferred
  • Potential for travel (US and International)