Sr. Biostatistician II

Clinical Irvine, California


Description

This position will be primarily responsible for statistical design, analysis of clinical research studies, and 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 Biostatistics, Statistics, Epidemiology, Outcomes Research, Economics.
  • 2+ years relevant work experience in statistical analysis and interpretation of data.
  • Proficient programming in various languages (R, SAS, SPSS, etc.)
  • Extensive knowledge of statistical methods
  • Extensive knowledge of mathematical modeling
  • Strong project management and problem-solving skills, and ability to effectively lead and collaborate with all functions.
  • High attention to detail including proven ability to manage multiple, competing priorities.
  • Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel.
  • Ability to manage multiple projects simultaneously.
  • Thorough understanding of biostatistics, pharmacoepidemiology, and outcomes research methods in clinical or observational studies.
  • Expertise in observational study designs used in pharmacoepidemiology
  • Understanding of the communalities and differences between primary and secondary data collection.
  • Programming experience with R, SAS or other statistical software packages
  • Knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
  • Knowledge of statistical methods for observational studies
  • 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.
  • Ability to work independently on routine assignments and under little supervision on new assignments.
  • Medical device trials experience preferred
  • Detail oriented with ability to deliver high quality product consistently and on time