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BIOSTATISTICIAN, SENIOR
Job Title: BIOSTATISTICIAN, SENIOR
Job Code: 2683
FLSA: E
Job Level: 73
Revised Date: 04/01/2022
Job Family: JF 05
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.
Work Performed
With minimal or no guidance, prepares statistical analysis plans. 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 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. 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 efficiently, 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. 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 and maintains programming skills even when delegating many programming tasks to others.
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.
Handles and secures highly confidential and sensitive analyses and documentation. Supports the preparation of Data and Safety Monitoring Board 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
Collaborates effectively and confidently with a variety of types of individuals: programmers, statisticians (both junior and senior), medical personnel, and representatives within the business community. Consistently demonstrates leadership qualities in a variety of settings and through multiple experiences and ability to manage project responsibilities independently across a variety of different projects
Consistently handles multiple competing projects and deadlines. Presents information on topics relevant to statistics and statistical operations at internal statistics meetings. Gives oral presentations of key statistical methods, operational issues, study results, or project status at trial or clinical project meetings.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Qualifications at this Level
Education/Training
Position requires a minimum of a Doctoral degree in (bio) statistics or related field and 0-2 years of relevant experience, or a master's degree in (bio) statistics or related field and 4 years of relevant experience, or a bachelor's degree in (bio) statistics or related field and 6 years of relevant experience.
Experience
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR 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.
Skills
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
