I saw this job posted and thought it might be helpful to someone....
Biostatistician (Midtown East)
Who we are:
The Cardiovascular Research Foundation, headquartered in New York City, has been dedicated to research and education in the broad subspecialty of interventional cardiology and endovascular medicine for over fifteen years.
By establishing the safe use of new technologies and pharmacologic agents, CRF has played a major role in the remarkable advances in survival and quality of life being realized for patients with cardiovascular disease.
Become a part of our team and help CRF serve as a major catalyst in the field of interventional vascular medicine.
Biostatistician, Clinical Research Operations
The biostatistician brings statistical expertise to the design, conduct, analysis and reporting of clinical studies, in the pre-clinical, Phases I to IV, and post-marketing, stages of study. Duties include, but are not limited to:
• Applies statistical theory and methods to the design and analysis of clinical trial data; prepares data analysis plans, assists with the preparation of manuscripts and writes reports describing results of statistical analysis; presents results as requested in the form of text, tables, tabulations, and graphs.
• Represents the Biometrics, Data Management & Programming group in regulatory agency and project team meetings.
• Provides statistical support and consultation to management for grant and request for proposal preparations, as well as study protocols; serves as project biostatistician/representative to sponsors regarding study design.
• Reviews study protocols in development to ensure that the study case report forms and database can adequately capture data needed for the SAP; creates and maintains statistical and informational databases.
• Collaborate with physicians, nurses, database managers and other research scientists on the design, implementation and analysis of clinical studies.
• Provides orientation and facilitation of data quality reviews and function as an active participant of the Data Quality Review Meeting (DQRM).
• Responsible for the development and review of corrective action plans as requested on internal/external audits and implements plans as required.
• Conducts all job duties within context of Good Clinical Practice (GCP) and according to company SOPs and guidelines.
• Additional duties as assigned.
• MS or PhD in Statistics or Biostatistics.
• Minimum of 3-5 years experience in clinical trials, preferably in a pharmaceutical or contract research organization environment.
• Proficiency in SAS programming skills in performing statistical analyses and generating report-ready data outputs; knowledge of other statistical analysis software.
• Application experience in cardiology desirable; especially survival and categorical data analysis methods.
• Ability to understand and interpret complex mathematical/statistical problems.
• Strong understanding of the clinical trial process from data acquisition to data reporting.
• Experience in authoring manuscripts, SOPs, clinical documents and templates required.
• Proficient with Microsoft Outlook, Word, and Excel; basic understanding of database programs is extremely helpful.
• Must possess excellent communication and writing skills, ability to multi-task and set priorities, excellent organizational planning, project management and time management skills.
• Choice of health plans that include medical, dental and vision coverage.
• Company-paid short-term and long-term disability and life insurance.
• Health and dependent care flexible spending accounts.
• Pre-tax travel expenses through TransitChek program.
• 401(k) plan with a company match that is fully vested in just three years of employment.
• Generous paid time off (PTO) entitlement CRF employees accrue four weeks of PTO in first year of employment; five weeks of PTO in the second through fourth years.
• Ten paid holidays each year.
• Discounted health club membership.
To be considered for this opportunity, please submit your resume, including salary requirements and availability to the Recruiter-fax (212) 851-9280 or email to [email protected]
Please refer to job title "Biostatistician" in your cover letter.
Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org
CRF is an equal opportunity employer.