Principal Biostatistician, Senior

About the Opportunity

Under the guidance of the Director of Biometrics 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, medical affairs, 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 determination and implementation of statistical methodology and interpretation of statistical analysis results.

TTC: $198,000 - $210,000

• Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.

Responsibilities

• Collaboration, communication, leadership, and project management

• 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.

• Statistical analysis planning, generation, and interpretation

• 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.

• 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 may include administrative operations and data management support.

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