Brigham and Womens Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race sex color religion national origin sexual orientation protected veteran status or on the basis of disability.GENERAL SUMMARY/OVERVIEW STATEMENT:
This position involves helping to manage the TIMI statistical group projects by determining work assignments for statistical programming and analyses from multiple international clinical trials. The incumbent is required to have a comprehensive understanding of each trial in order to be able to effectively determine and plan work flow within the group. The incumbent will work in collaboration with the Director of Biostatistics for the TIMI Study Group to assign projects to members of the statistics group and to help oversee projects to assure accurate results which are completed in predetermined timeframes. The incumbent will ensure accurate and timely input to the project tracking database from the other members of the statistical group. In collaboration with the Director of Statistics the incumbent will review completed analyses and projects before information is provided to the requesting investigator. The incumbent will also collaborate with physician investigators to develop statistical plans for investigational protocols.The incumbent will be responsible for some of the projects being undertaken by the statistical group in support of the TIMI investigators. This task involves daily checking with the other members of the Group identifying areas of concern answering questions regarding technical and data handling issues which crop up with the Group and referring issues to the Director of Statistics.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
1.Possess a solid understanding of the purpose objectives and goals of each trial.
2.Help assign and oversee the workload of TIMI statistical group on an ongoing basis. Routinely monitor the progress of projects and provides guidance and assistance as needed.
3.Collaborate with physician investigators to develop statistical plans for investigational protocols.
4.Collaborate with the physician investigators with the preparation of manuscripts abstracts and presentations at scientific meetings.
5.Routinely update the Director and physician investigators on the status of projects and work within the group.
6.Create new analytic techniques under the direction of the Director of Statistics.
Statistical Testing/Programming
1.Determine and/or verify correct statistical testing to be performed in each analysis request.
2.Performs statistical testing as directed from the Director.
3.Rearranges data from new datasets from a SAS format to a format that allows for accurate integration and pooling across trials.
4.Oversee the performance statistical testing to specified datasets.
5.Oversee accurate rearranging of data from new datasets from a SAS format to a format that allows for accurate integration and pooling across trials.
6.Oversee the compilation and organization of data for transmission to investigators sponsors or the Director.
7.Coordinate data from all trials performed by the TIMI Study Group as well as all prior and current TIMI Trials.
8.Evaluate maintain and update the status of all datasets on an ongoing basis and as needed.
9.Compile and organize data for transmission to investigators sponsors or the Director of Statistics.
10.Create graphical displays of data at the direction of the Director of Statistics
11.Monitors databases for quality assurance purposes. Ensures regulatory compliance.
12.Perform other duties as required and as appropriate.
Administrative
1.Reviews output from staff before dissemination to others.
2.Assure the maintenance of an up to date electronic archive recording data requests statistical testing and data transmissions performed.
Organizational
1.Effectively interact with other members of the organization to reach the prespecified goals of each trial.
2.Performs other duties as required and as appropriate.
Day Shift
QUALIFICATIONS:
MS/MPH in biostatistics or a related field with a minimum of five years experience or PhD in biostatistics or related field with a minimum of 12 years experience with data analysis and programming in a clinical trials setting such as pharmaceutical or CRO.
Familiarity with survival analysis and longitudinal data analysis
required.SKILLS/ABILITIES/COMPETENCIES REQUIRED:
Ability to work independently as well as part of a team
Possess managerial skills in order to interact with both with statistical personnel physician investigators and other members of the research group. Possess strong analytical skills
Ability to prioritize assignments multitask make decisions based upon sound principles and independently problem solve.
Ability to draft plans to resolve inaccuracies or other problematic situations. Ability to make decisions related to issues in the statistical group pending final approval from the Director.
Ability to develop novel ways to coordinate manage and report data if required by new trials.
Demonstrated sound independent judgment and competencies in clinical research.
WORKING CONDITIONS:
Busy office environment with frequent deadlines