Biostatistician, III

About the Team

You will work with data scientists and medical doctors, daily who will help to integrate software solutions with the healthcare diagnosis systems, all in an environment conducive to productivity, brainstorming, and close collaboration across teams, with each team member being an integral part of the creative process.

About the Opportunity

Under the guidance of the Senior Statistician and Chief Medical Officer, perform intermediate and advanced level statistical analysis and programming for a broad range of medical research projects. Collaborate closely with a cross-functional project team, physicians, regulatory, product development, evidence generation, market access and reimbursement, and the core laboratory with regard to statistical aspects of each project. Demonstrate expertise in study design, implementation of statistical methodology, and interpretation of results in order to serve as a resource

Salary: $125,000 - $150,000

Responsibilities

• • Collaboration, communication, leadership, and project management

  Collaborate effectively with statisticians, medical personnel, product developers and regulatory experts within Cleerly under limited guidance of a supervising biostatistician. Contribute constructively to project discussions in team meetings. Demonstrate excellent written and oral proficiency in the English language. Adhere to the standard operating procedures (SOPs) and best practices of Cleerly as they apply to documentation and validation of research methodology. Manage project responsibilities with decreasing levels of supervision or regular support. Take initiative to complete project-specific responsibilities with minimal supervision. Demonstrate ability to multitask and meet deadlines. Build documentation and organizational skills to effectively return to a project or manuscript after long intervals.

  • Statistical analysis planning, generation, and interpretation

  Perform intermediate-level statistical analysis at all phases of a research project, from protocol development and study design through final analysis and reporting of results and regulatory/manuscript submission & revisions with guidance from the supervising biostatistician. Evaluate research studies and recommend statistical procedures, including, but not limited to, hypothesis tests, regression models and multivariate analysis to analyze the data. Contribute meaningfully to discussions of analyses and identify next steps for analyses. Prepare statistical analysis plans independently. Prepare comprehensive statistical reports to communicate findings. Prepare statistical components of presentations, abstracts, study protocols, regulatory submissions, and manuscripts. Learn new statistical methods as needed, and apply new skills to future projects. Perform intermediate and advanced statistical analyses, including but not limited to generating descriptive and test statistics, and performing high-level statistical modeling. Check results for accuracy and consistency. Demonstrate clinical/statistical areas of expertise and serve as resource in this area.

  • Programming and data documentation

  Program and develop analysis datasets using SAS; combine multiple disparate raw data sets, execute standard cleaning and quality control procedures, and derive analytic variables as required. Demonstrate good programming practices through proper documentation, commenting, and readability. Perform complex programming using advanced options in SAS procedures and macros with increasing efficiency. Participate actively in designing and validating analysis data sets, programs, and statistical output products (tables, listings, figures). Perform appropriate and adequate code checks to ensure accuracy of results.

  • Other Responsibilities

  As part of a new startup with a highly collaborative culture, perform other related duties and "pitch in" where needed. In the early stages, these duties will include administrative operations.

Requirements

• Position requires a minimum of a Doctoral degree in (bio) statistics or related field and no relevant experience, or a Master's degree in (bio) statistics or related field and 4 years relevant experience, or a Bachelor's degree in (bio) statistics or related field and 6 years relevant experience.
• Contribution to analysis of clinical research projects, and/or participation in preparation of academic manuscripts, regulatory submissions, or other written summaries of analysis results. Experience with development and execution of statistical analysis plans and thorough experience with SAS including data manipulation and procedures for data analysis (proc univariate, means, freq, t-test, genmod, lifetest, proc phreg, proc sgplot). Experience with statistical analysis of time-to-event data with censoring, multivariate analysis of predictors of time-to-event data, continuous data, and binary outcomes. Experience with repeated measures data is a plus. Experience in the diagnostic or therapeutic medical device field , including regulatory submissions, strongly preferred. Solid command of the English language is required.

• Energy and enthusiasm consistent with working for a startup; strong technical presentation skills; strong organizational skills; ability to remain organized and productive in a fast-paced work environment with competing priorities; work independently, diligently, and efficiently on assigned tasks and projects, and collaborate seamlessly with colleagues from other technical teams.
• Desirable experience includes knowledge of cardiovascular imaging and clinical data.