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POST DATE 5/2/2020
END DATE 6/2/2020
JOB DESCRIPTIONThe Biostatistician collaborates with both internal and external customers to determine study design, contributes to protocol development, writes statistical analysis plans, performs statistical analysis and inference, and writes and presents reports ensuring high-quality statistical support is provided for clinical trials.
Contributes to the design of clinical studies by:
* Leading the development of statistical analysis plans and programs to perform analyses and display study data
* Reviewing protocols and case report forms to ensure that protocol objectives are met and standards are maintained
* Generating treatment allocations in randomized clinical research studies and ensuring proper implementation
* Defining the contents of the statistical tables and reports, including necessary explanation of data and analysis and identifying any programming constraints
Ensures the quality and integrity of statistical data by:
* Assisting with management of statistical activities for assigned projects, ensuring timelines are met
* Understanding, applying and providing training in advanced and sometimes novel statistical methods
* Resolving complex SAS programming issues as well as other related programming issues
* Performing quality check of the SDTMs and SAS datasets against the source data provided to ensure submission requirements are met
* Reviewing clinical/statistical reports
* Generating and/or validating patient data listings, statistical analysis summary tables and reports for the regulatory Annual Reports and submissions, investigator institutional review boards (IRBs), conferences, etc.
* Generating and/or validating reader performance metrics related to inter/intra reader variability, read monitoring boards, etc.
Analyzes and interprets statistical data by:
* Performing appropriate statistical analysis
* Creating, documenting, and maintaining detailed data definition and inventory of all data and programs
* Writing statistical analysis methodology summary or sections, interpreting results to ensure validity of conclusions
* Generating study reports to be distributed to internal and external monitoring committees and regulatory bodies
* Identify outstanding data errors and work with clinical study teams to ensure the up-to-date and error free data are available at the time of analysis
* Develops metrics and generates quality control reports to optimize the performance of clinical sites and the coordinating center
Maintains Quality Service and Departmental Standards by
* Reading, understanding and adhering to organizational Standard Operating Procedures ( SOP )
* Assisting in establishing and enforcing departmental standards
Contributes to team effort by
* Working with internal staff to resolve issues
* Exploring new opportunities to add value to organization and departmental processes
* Helping others to achieve results
* Performing other duties as assigned
Maintains Technical and Industry Knowledge by
* Attending and participating in applicable company-sponsored training
* Master s degree in statistics, mathematics, or biostatistics required
* SAS Certified Professional considered a plus
* 5+ year statistical modeling experience in pharmaceutical related industry required
* Working knowledge of statistical programs such as SAS
* Proven ability in analyzing data, as well as mathematical, inductive, and deductive reasoning
* Advanced understanding of regulatory requirements and implications related to statistical processing and analysis in clinical trials
* Experience with the design and analysis of clinical trials is required
* Proven ability in problem solving and critical thinking
Additional skill set:
* Ability to work in group setting and independently; ability to adjust to changing priorities
* Excellent attention to detail and orientation toward meticulous work
* Strong interpersonal and communication skills, both verbal and written
* Strong documentation and organizational skills
* Ability to project and maintain a professional and positive attitude
Other: Computer work for long periods of time.
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.