Statistical Programmer II

Clinical Irvine, California


Description

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

Responsibilities

  • 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
Qualifications
  • 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