Principal Biostatistician

Clinical Irvine, California


Description

This position will be primarily responsible for statistical design and analysis of clinical research studies as well as for providing statistical expertise in support of publication efforts and regulatory submissions.

Responsibilities

  • Work closely with clinical teams in designing clinical studies and serve as statistical lead on multiple clinical studies
  • Develop statistical analysis plans (SAP), conduct statistical analyses, and provide statistical input to clinical study reports (CSRs)
  • Provide input on case report forms and clinical databases to ensure quality data collection
  • Program clinical research data for ease of analysis on ongoing basis, particularly for observational, hypothesis generating studies
  • Conduct exploratory analyses to inform design of new clinical trials
  • Collaborate with core stakeholders to provide statistical expertise in support of product development and regulatory submissions
  • Provide statistical expertise and conduct ad hoc data analysis for publication/abstract submissions
  • Communicate statistical results to medical writing team to ensure accurate interpretation
  • Conduct statistical analyses for data monitoring committees, if requested
  • Provide input on publications and data analysis

Qualifications
  • PhD. in Statistics, Biostatistics or related fields, with minimum 4-6 years of experience in clinical trials, or M.S. with minimum of 8-10 years
  • Computer science/programming education and experience strongly desired
  • Proficiency in SAS and/or R statistical software
  • Proficiency in data programming to facilitate statistical analyses
  • Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel
  • Ability to manage multiple projects simultaneously
  • Managerial track preferred
  • Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
  • Regulatory submission experience for clinical trial studies
  • Knowledge of statistical methods for observational studies
  • Extensive understanding and knowledge of regulatory guidelines relevant to in Pharma or Medical Device research setting
  • Experience in trial and endpoint simulations for sample size and power calculation
  • Excellent written and verbal communication skills
  • Healthy disdain for the status quo
  • Ability to thrive in a fast-paced and dynamic early stage company work environment
  • Medical device trials experience preferred
  • Detail oriented with ability to deliver high quality product consistently and on time