Serves as a functional lead statistician for clinical trials in collaboration with CROs. Responsible for statistical project management, including financial oversight. Provide expert statistical review and approvals of protocols, particularly high-profile studies (e.g. those to be submitted to regulatory agencies). May represent study team in meetings with sponsors and regulatory agencies, and provide statistical expertise at meetings with funders. Resource to other statisticians and researchers with respect to complex analytic methodology and novel approaches to research problems. Provide technical, scientific, and/or project management leadership. Coordinate or lead training of statisticians or non-statistician personnel. Serve as consultant for researchers on analysis methods and study design. May serve as a Principal Investigator.
- Serve as lead statistician for studies of simple to intermediate complexity or strong supportive role to lead statistician on complex or high-profile studies.
- Serve as statistical consultant to researchers on study design, sample size and analysis of clinical trials and other studies of simple to moderate complexity.
- Write statistical sections of protocol.
- Serve as Independent Statistician to DSMB on more complex analyses (e.g. those involving stopping rules).
- Contribute to development and maintenance of departmental systems, including management tools.
- Provide senior-level review of protocols written by investigators in other departments or divisions. Referee manuscripts.
- Contribute to proposal development.
- Serve as consultant to researchers regarding study design, sample size, analysis methods for studies at all levels of complexity.
- Stay current on relevant research and statistical methodologies via statistical training, self-study, internal training and courses, external conferences and courses, etc.
Applied Knowledge & Skills:
- Deep understanding of scientific and ethical principles in research study design.
- Able to communicate statistical concepts to non-statistically-trained research colleagues
- Able to interact effectively with study clinicians and researchers in a consultation setting.
- Extensive knowledge of a wide variety of study designs.
- Proposes and may lead new initiatives
- Excellent interpersonal communications skills (verbal & written) in English
Problem Solving & Impact:
- Problems are varied, requiring analysis or interpretation of complex factors or situations
- Uses logic and understanding of scientific reporting to make appropriate decisions regarding data handling
- Uses good judgment in projecting and managing resources and timelines
- Anticipates problems and proactively works to forestall them.
- Exercises leadership within division, research teams
- Typically reports to Director.
- Works independently with minimal supervision.
- With minimal supervision, manage high volume work flow.
- Uses independent judgment to execute duties and responsibilities.
- Oversees work of more junior statisticians.
- May directly supervise more junior statisticians.
- Masters’ degree (or international equivalent) in statistics, biostatistics, bioinformatics or similar curriculum.
- PhD preferred
- Typically requires 8 – 12 years’ of research study design and analysis experience, with strong proficiency in SAS programming.
- Advanced skills in multiple statistical areas and/or therapeutic indications.
- Excellent interpersonal communication skills, verbal and written English.
- Advanced knowledge in statistical aspects of study design.
- Advanced experience providing statistical consultation to researchers.
- Experience working with or at Contract Research Organization (CRO)
- Experience with FDA clinical trial regulations
Typical Physical Demands:
- Typical office environment.
- Ability to sit and stand for extended periods of time.
- Ability to lift 5-50 lbs.
Technology to be Used:
- Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand held devices.
This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.