Principal Biostatistician – Senior

Principal Biostatistician – Senior

Requirements

• Position requires a minimum of a Doctoral degree in (bio) statistics or related field and 8 years of relevant experience, or a Master’s degree in (bio) statistics or related field and 12 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, logistic).
• 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 ROC/AUC analyses.
• Experience with repeated measures data is a plus.
• Experience in the diagnostic or therapeutic medical device field 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.

Responsibilities

• Collaborate effectively with evidence generation, medical personnel, and external clinical collaborators.
• Collaborate effectively with clinical to translate clinical questions and objectives into measurable statistics and hypotheses.
• 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.
• Function independently and manage multiple simultaneous project responsibilities and deadlines.
• Take initiative to complete project-specific responsibilities with minimal to no supervision.
• Demonstrate ability to multitask and meet deadlines.
• Build documentation and organizational skills to effectively return to a project or manuscript after long intervals.
• Perform intermediate and advance-level statistical analysis at all phases of a research project, from protocol development and study design through final analysis and reporting and interpretation of results and manuscript and abstract submission & revisions.
• 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.
• 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.
• 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 may include administrative operations and data management support.

Preferred Qualifications

• Desirable experience includes knowledge of cardiovascular imaging and clinical data.