Biostatistician, Medical Outcome research - FNIH (Telecommute)

~The Foundation for the National Institutes for Health (FNIH) (www.fnih.org) is seeking to hire an experienced Biostatistician to be responsible for the statistical aspects of study plans and data analyses involving health outcomes of interest and analytical methods. This position will generate statistical analysis plans; determine and implement appropriate statistical methodology for evaluation, interpretation, and reporting of various healthcare datasets; oversee SAS programming of datasets; and interact closely with the systems integrator. The Biostatistician will report directly to the Executive Director of the Observational Medical Outcomes Partnership.

The Observational Medical Outcomes Partnership (omop.fnih.org) is a public-private partnership designed to protect human health by improving the monitoring of drugs for safety and effectiveness. The partnership began in Q4-2008 and will conduct a two-year research initiative to determine the contribution and utility of using existing healthcare databases to identify and evaluate safety issues of drugs already on the market.

OMOP draws on the expertise and resources of the pharmaceutical industry, academic institutions, non-profit organizations, the Food and Drug Administration (FDA), and other federal agencies. It is funded and managed through the Foundation for the National Institutes of Health. In addition to sponsoring specific research efforts, OMOP will create a set of tools—such as data models, experimental protocols, and database evaluation tools—that will be placed in the public domain to encourage research by a broad community of scientific investigators. All project results will be made public in accordance with the public health mission of the partnership. These will include comprehensive reports on scientific and technical findings, lessons learned, and peer-reviewed articles on the experimental findings by our sponsored investigators.

ESSENTIAL FUNCTIONS

• Manage and lead the statistical components of protocols which meet project objectives
• Provide direction/leadership to programmers and statisticians
• Collaborate in protocol development as required (completing statistical section of protocols)
• Write and review protocol analysis plans and create output / table shells
• Provide statistical input and support to study reports and for publication
• Review and comment on the work of others; maintain confidentiality; and consult with clinical experts
• Prepare reports and related documents; direct the work of others; write in a clear and understandable manner; exercise independent judgment

MINIUMUM QUALIFICATIONS

• Master’s or Ph.D in Statistics/Biostatistics with at least 5 years of pharmaceutical or biotechnology industry experience
• Demonstrated experience with statistical software packages such as SAS; experience with large clinical or medical claims databases required.
• Sound knowledge of theoretical and applied statistics with appropriate training and experience, and demonstrated expertise in designing and implementing clinical statistical and data analysis plans
• Experience writing, reviewing, and implementing clinical statistical analysis plans
• Ability to prospectively identify problems based on statistical knowledge and prior experience and provide alternatives to circumvent anticipated problems.
• Skills with different software tools or in other programming languages that can be used to create tools that will impact efficiency of work for group, e.g. to automate certain activities.
• Evidence of ability to work proactively and independently in a team environment and meet deadlines.
• Strong analytical, written, and verbal communication skills.
• High degree of personal integrity and interpersonal skills.

Location: Virtual, office in DC

Please email your resume and indicate in the email subject line which position you are applying for to: ewelebob [at] fnih.org

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