Biostatistician

Clinical Redwood City, California


Description

As a member of the Clinical Research department, the Biostatistician brings statistical expertise to the design, conduct, analysis, and reporting of clinical studies. The Biostatistician works as a member of a cross-functional team and continuously strives to ensure timely delivery and scientific validity of results. He/she will work closely with the other functional areas within the company to ensure seamless, accurate, and timely delivery of results. The Biostatistician leads development of statistical analysis plans and supports analysis of various datasets to meet regulatory submissions and scientific publication needs. The Biostatistician leads the data analysis of clinical study databases and commercial databases/datasets to support generation of scientific evidence. This position will be based in the Redwood City, CA office.

Job Responsibilities:

  • Develops Statistical Analysis Plans (SAPs) and leads the execution effort for assigned studies
  • Develops statistical programs as necessary to ensure the accuracy of the planned and completed analyses or exploratory analyses
  • Reviews protocols and contributes to protocol statistical analysis sections and generates study randomization scheme when appropriate
  • Authors results sections of the clinical study reports and supply statistical input for regulatory submissions and in response to regulatory questions
  • Provides independent validation of the statistical content in study documents including randomization, study reports, briefing documents, patient brochures, publications, and other content delivered to external entities
  • Participates in developing case report forms and clinical databases and participates in data cleaning to ensure quality data collection
  • Programs SAS to integrate and reconcile data from external sources for past, current, and future planned clinical trials
  • Generates SAS code to help automate weekly reports created by the Clinical Research team
  • Generates and quality-checks summary tables, data listings, and graphs for in-house analyses of study data for publications using SAS standard coding practices
  • Creates/acquires tools to improve programming efficiency or quality and as needed, validates work of other programmer/analysts and statisticians
  • Assists in the creation/review of data management plans, specifications for datasets, and annotated eCRFs
  • Establishes monitoring of data transfers for ongoing trials to identify study conduct or data quality issues
  • Supports data queries from other functional groups (Technology, Production, Regulatory, and Marketing)
  • Assists in the development and ongoing updates of data entry and data handling guidelines, SOPs, eCRFs, and other study support documentation

Skills Needed:

  • Expert knowledge of SAS programming and associated features and their applications in medical device research and in particular, a clinical trial data setting
  • Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis, and reporting of analysis results
  • Willingness to help out in other areas of clinical research, trial design and planning, trial management, data management, and report writing
  • Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
  • Track record of generating new ideas and solutions to data analysis
  • Thorough understanding of relational database components and theory
  • Excellent oral and written communication skills
  • High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
  • Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
  • Excellent written and oral English communication skills required
  • Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel and PowerPoint
  • Must have sound understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to a Pharmaceutical/Medical Device research setting

Educational Requirements & Work Experience: 

  • PhD in Statistics/Biostatistics and 3-5 years of clinical trial experience within the medical device, pharmaceutical, biotech industries
  • Masters in Statistics/Biostatistics and 5+ years of clinical trial experience within the medical device, pharmaceutical, biotech industries
  • A minimum of 3 years hands on relevant career experience in the pharmaceutical, medical device, or biotechnology industry
  • Experience in cardiovascular medical device clinical research a plus
  • Experience with FDA a plus

Company Summary:

HeartFlow, Inc. is a medical technology company redefining the way heart disease is diagnosed and treated. Our non-invasive HeartFlow FFRct Analysis leverages deep learning to create a personalized 3D model of the heart. By using this model, clinicians can better evaluate the impact a blockage has on blood flow and determine the best treatment for patients. Our technology is reflective of our Silicon Valley roots and incorporates decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRct Analysis is commercially available in the United States, Canada, Europe and Japan. For more information, visit www.heartflow.com.

www.heartflow.com

HeartFlow, Inc. is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by applicable law. Hiring, transferring and promotion practices are performed without regard to the above listed items.

Positions posted for HeartFlow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.