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BIOSTATISTICIAN, PRINCIPAL
Job Title: BIOSTATISTICIAN, PRINCIPAL
Job Code: 2684
FLSA: E
Job Level: 92
Revised Date: 04/01/2022
Job Family: JF 05
Occupational Summary
Demonstrates and shares expert technical knowledge in one or more areas of specialization, acquired through comprehensive experience. Leads broad-based projects and/or complex multiple-protocol projects. Manages trial/project responsibilities independently and with consistently superior quality. Demonstrates thorough applied technical knowledge of statistical methodologies relevant to clinical research.
Work Performed
Functions as an independent statistical and operational consultant in a variety of study phases and therapeutic disciplines. Leads broad-based projects and/or complex multiple-protocol projects. Demonstrates and shares expert technical knowledge and leadership in one or more areas of specialization, acquired through comprehensive experience (examples: therapeutic area; type of trial, project, or data; statistical methodology; unique collaboration; technology solution; education and mentoring).
Demonstrates superior collaborative and communication skills; interacts effectively and confidently with a variety of types of individuals, including programmers, statisticians (both junior and senior), medical personnel (physicians, nurses), and representatives within the pharmaceutical, medical device, biotechnology, and regulatory community
Provide mentoring and serves as a resource by less experienced statisticians and/or programmers. Coordinates and gives regular technical presentations on topics relevant to statistics and statistical operations at internal statistics and/or manuscript meetings. Gives technical presentations to a variety of external audiences. Mentors medical community in working with statisticians, development and writing manuscripts, and analytic methods
Represents the functional group in internal and external business development discussions related to current and future projects (trials, registries, and publications). Delivers presentations about the capabilities and operations of the functional group for internal as well as external clients in the pharmaceutical, medical device, or regulatory community
Consistently manages projects and analyses at the level of a senior statistician or higher and handles multiple competing projects and deadlines with success. Develops and documents processes to streamline work, particularly in area(s) of specialization. Coordinates resources required to meet needs of projects (as applicable to role) - Assess availability of statistics and programming resources for support; Allocate resources among trials/project/manuscripts; Establish and monitor priorities, schedules and timelines; Meet regularly with statisticians, programmers, and supporting staff to assess progress and Document current status and progress.
Writes statistical text for study reports, clinical publications, methods sections, and analysis plans for incorporation in abstracts, manuscripts, grants, and final statistical reports. 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. Independently and proactively assesses how clinical trial/project results fit in the context of results from similar clinical trials/projects in the broader field. Serves as a resource for other statisticians about a broad spectrum of analysis methods.
Demonstrates thorough understanding of clinical trial/project data collection processes and data elements collected (or to be collected) in a study, and shares knowledge with collaborators, fellow statisticians, and programmers. Designs analysis data set specifications and provides input on those prepared by junior statisticians or statistical programmers. Takes appropriate initiative to guide the process of resolution of data issues. Programs all levels of code, accurately and efficiently 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 such activity to the attention of project leader, and follows up as needed to ensure the activity 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
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 and monitors the adherence of others under mentorship.
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 6 years relevant experience, or a master's degree in (bio)statistics or related field and 8 years relevant experience, or a bachelors degree in (bio)statistics or related field and 10 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. Expert technical knowledge in one or more areas of specialization is required.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Demonstrates ability to communicate effectively with all types and levels of internal and external collaborators. Thorough experience with SAS, solid command of the English language, strong technical writing skills, and multiple and varied prior trial/project experiences are required.
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.
