This position will be primarily responsible for statistical design and analysis of clinical
research studies as well as for providing statistical expertise in support of publication
efforts and regulatory submissions.
- Work closely with clinical teams in designing clinical studies and serve as statistical lead on multiple clinical studies.
- Develop statistical analysis plans (SAP), conduct statistical analyses, and provide statistical input to clinical study reports (CSRs).
- Provide input on case report forms and clinical databases to ensure quality data
- Program clinical research data for ease of analysis on ongoing basis, particularly for
- observational, hypothesis generating studies.
- Conduct exploratory analyses to inform design of new clinical trials.
- Collaborate with core stakeholders to provide statistical expertise in support of product development and regulatory submissions.
- Provide statistical expertise and conduct ad hoc data analysis for publication/abstract submissions.
- Communicate statistical results to medical writing team to ensure accurate interpretation.
- Conduct statistical analyses for data monitoring committees, if requested.
- Provide input on publications and data analysis.
- Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses.
- Regulatory submission experience for clinical trial studies.
- Knowledge of statistical methods for observational studies.
- Extensive understanding and knowledge of regulatory guidelines relevant to in Pharma or Medical Device research setting.
- Experience in trial and endpoint simulations for sample size and power calculation.
- 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.
- Ph.D. in Statistics, Biostatistics or related fields, with minimum 4-6 years of experience in clinical trials, or M.S. with minimum of 8-10 years.
- Computer science/programming education and experience strongly desired.
- Proficiency in SAS and/or R statistical software.
- Proficiency in data programming to facilitate statistical analyses.
- Proficiency in MS Office Suite including Word, PowerPoint, Access, and Excel.
- Ability to manage multiple projects simultaneously.
- Managerial track preferred.