Job Description
Occupational Summary
- Manages trial/project responsibilities independently.
- Handles multiple competing projects and deadlines, and coordinates all the statistical needs of each clinical trial/project.
- Performs intermediate and advanced statistical analysis and programming for multi-center phase I-IV clinical trials and/or clinical research projects.
- Collaborates closely with a cross-functional trial/project team, physicians, and external government or industry representatives with regard to statistical aspects of each clinical
trial/project.
- Ensures that work products are generated within specified time frames, which can be driven by medical drug/device development-related deadlines.
- Demonstrates a comprehensive understanding of the clinical drug and/or device development process.
- Occasionally represents the functional group in internal and external business development meetings.
- Serves as a resource for less experienced programmers and/or statisticians.
- Participates on DCRI-wide committees and initiatives.
- Takes initiative to constructively resolve system-wide problems.
Work Performed
Statistical Analysis Planning, Generation, and Interpretation
- Prepares statistical analysis plans with minimal or no guidance
- Performs and interprets basic and complex analyses without guidance Uses statistical and medical understanding to propose and perform additional analyses appropriately and independently
- Learns new statistical methods and applies new skills to future projects
- Documents analyses, creates summaries, and presents results in written and verbal form to requestors
- Writes statistical text for study reports and clinical publications
- Prepares methods sections and analysis plans for incorporation in abstracts, manuscripts, grants
- Demonstrates documentation and organizational skills to effectively return to a manuscript project after long intervals during which no progress was made by other members of the project team, and
guides others in how best to accomplish this
- Demonstrates ability to work on any phase of a manuscript project, from initial meeting with an investigator to final review of a manuscript prior to submission for publication, without
guidance
- Discusses analytic issues related to other findings within a clinical trial/project
- Independently and proactively assesses how clinical trial/project results fit in the context of results from similar clinical trials/projects in the broader field
- Contributes meaningfully and creatively to discussions of analyses and proactively identifies next steps for analyses
- Serves as a resource for other statisticians about a broad spectrum of analysis methods
Programming and Data Set Documentation
- Designs analysis data set specifications and provides input on those prepared by junior statisticians or statistical programmers
- Writes own SAS and/or S-plus code, finds errors, corrects, and validates output and results
- Performs complex programming, uses complicated SAS procedures and options
- Programs analysis datasets using SAS and/or reviews those programmed by others to ensure quality products; combines multiple disparate raw databases and derives analysis variables accurately
- Programs efficiently
- Considers alternative programming approaches to improve quality and/or efficiency
- Collaborates effectively with statistical programmers that support clinical trial/projects
- Identifies potential data problems from analytic queries and takes appropriate initiative to guide the process of resolution
- Demonstrates thorough understanding of clinical trial/project data collection processes and data sets and shares knowledge with collaborators, fellow statisticians, and programmers
- Possesses broad programming abilities and shares them with others by consultation and example
- Maintains programming skills even when delegating many programming tasks to others
Contribution to Multi-Center Clinical Trials and/or Clinical Research Projects
- Guides all statistical aspects of a trial/project without guidance
- Collaborates with project leader, principal investigator, other clinical investigators, and external government or industry representatives to affect significant decisions regarding the
trial/project, and to jointly achieve objectives and timelines
- Represents the functional group in project team meetings and contributes constructively to project discussions
- Understands the contracted scope of work and forecasts monthly hours expected to complete each trial/project
- Proactively identifies potential out-of-scope activity, brings to the attention of project leader, and follows up as needed to ensure that it is addressed in a timely manner
- Creates timelines for statistical project management without assistance
- Contributes to the thought process of endpoint selection and study design
- Calculates samples sizes, power calculations, and interim stopping guidelines without guidance
- Drafts statistical sections for study synopses and protocols, without guidance
- Generates project randomization sequences and random study drug kit numbers; provides input and review of telephone-based or internet-based randomization system specifications
- Provides review and approval of data collection tools, data correction criteria and procedures, identification of critical data fields, and endpoint collection documents
- Understands study data and the intricacies of the process through which it is being collected
- Coordinates and attends Data and Safety Monitoring Board (DSMB) meetings, with minimal or no guidance of a senior or faculty statistician, and drafts minutes of each meeting
- Handles and secures highly confidential and sensitive analyses and documentation
- Supports thepreparation of DSMB reports and final statistical and study reports, including those intended for regulatory submission, and collaborates with medical writers as needed
- Collaborates closely with investigators, sponsors, and other trial leadership to ensure that trial/project results and conclusions are presented accurately and without bias
- Leads the statistical team responsible for designing and validating analysis data sets, programs, and statistical output products (tables, listings, figures)
- Adheres to standard operating procedures of the functional department as they apply to documentation and validation of clinical research statistics Understands and proactively remains abreast of
guidelines from the FDA, ICH, EMEA, IRB, HIPAA, or other regulatory agency as they apply to statistics, programming, and handling of clinical data; monitors compliance to required standards of own
work and that of any individuals being mentored
- Demonstrates solid understanding of the clinical drug and/or device development process
Working at Duke
Duke employees are part of a premiere organization dedicated to excellence in education, research, and patient care. By working at Duke, we gain the opportunity and the responsibility to make a
real difference in the world. Take a closer look to find out why and whether you can help contribute to the legacy of great achievement and even greater promise at Duke.
Minimum Qualifications
Education
Position requires a minimum of a Doctoral degree in (bio) statistics or related field and 0-2 year's relevant experience, or a master's degree in (bio) statistics or
related field and 4 years relevant experience, or a bachelor's degree in (bio) statistics or related field and 6 years relevant experience.
Experience
Experience as a lead statistician on clinical trials and/or clinical research projects that have consistently provided high quality end products on time, and prior
supervision and/or guidance of lower level or less experienced employees is required. Thorough experience with SAS and solid command of the English language is required. Strong technical writing
skills and multiple and varied prior trial/project experiences desirable.