Senior Biostatistician

Date Posted
8/09/2018
Location
South San Francisco, CA
Job Id
201017

Senior Biostatistician

Biometrics South San Francisco, California

Description

The Senior Biostatistician will provide statistical support (e.g., study design and data analysis) across all Portola’s clinical studies, pre-clinical, and validation studies. The successful candidate will provide data mining for product development, global regulatory submissions, claims substantiation, post market surveillance, and tracking data optimization. These activities are in direct support of product approval for Portola’s drugs.

Responsibilities:

  • Assist the Director of Biostatistics with the design and analysis of clinical trials in healthy volunteers and patients
  • Provide biostatistics leadership to cross-functions, i.e. clinical science, project management, medical affairs, pharmacovigilance, and clinical operations
  • Author statistical analysis plans for individual studies, ISS and ISE
  • Provide input into CDISC standards across studies and programs
  • Collaborate on project development plans, regulatory, scientific and commercial projects
  • Assist with develop SOPs and ensure compliance with process & quality of deliverables within the development program
  • Support publication activities and scientific presentations
  • Maintain expertise in the field of biostatistics, and bring best practices and new methodologies in- house
  • Author or contribute to reports and/or scientific presentations and manuscripts
  • Perform statistical analysis, create summary tables, listings and figures in SAS and validate statistical analysis as defined in the analysis plan with oversight from supervisor
  • Prepare analyses that support regulatory submissions for product approval
  • Deliver results in a manner that is time-sensitive, high quality, proactive and communicative with collaborating entities and stakeholders
  • Perform sample size and power calculations
  • Assist in review of CRFs and edit checks; review and understand DM plans
  • Develop and maintain department tools, templates, guidelines, SOPs and systems
  • Work with Data Management partners to organize timely and accurate data extraction from EDC system into statistical programs for analysis
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