Statistical Programmer II

Clinical Irvine, California


This position will be primarily responsible for statistical programming, analysis of clinical research studies, and providing programming support of publication efforts and regulatory submissions.


  • Manages timely creation, review, completion, and delivery of statistical programming activities and deliverables of study projects. Performs acquisition/curation of data (RCT, RWE, Piblic etc.) including Pseudo-CDISC Standardization or full CDISC Standardization as necessary
  • Works with statistics/clinicians and other project team members on documenting/implementing programming endpoint algorithms across a project. Reviews and provides feedback of Statistical Analysis Plan (SAP)
  • Manage the end-to-end analytics of deliverables from data curation through final presentation which may include preparation for abstracts and manuscripts
  • Informs internal and external project team members of statistical programming requirements, deliverable status, and resource needs
  • Program clinical research data for ease of analysis on ongoing basis, particularly for observational, hypothesis generating studies
  • Conduct exploratory analyses with statistician to support publication/abstract submissions
  • Communicate statistical results to stakeholders to ensure accurate interpretation
  • MS in Statistics, Mathematics, or related fields.
  • 2+ years relevant work experience in statistical analysis and interpretation of data.
  • 2+ years relevant industry experience in Pharma, Med Device, CRO.
  • 2+ years clinical trial experience.
  • 2+ years clinical database experience and CDISC pipeline process.
  • Working knowledge of statistical methods.
  • Working knowledge of mathematical modeling.
  • Knowledge of software development packages (SAS, R, or other software packages).
  • 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.
  • Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses
  • Extensive understanding and knowledge of statistical methods for observational studies
  • Extensive understanding and knowledge of regulatory guidelines relevant to in Pharma or Medical Device research setting
  • 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