BIOSTATISTICIAN III, DCRI Statistics

Duke Careers

Durham, North Carolina

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Date Posted July 11, 2021
Industry Private Sector BioStat Jobs
Specialty Not Specified
Job Status Not Specified
Salary Not Specified

Description:

School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health . Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

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 and performs and interprets basic and complex analyses. 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
Discusses analytic issues related to other findings within a clinical trial/project. Understands how clinical trial/project results fit in the context of results from similar clinical trials/projects in the broader field. 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. Helps less experienced programmers and/or statisticians with programming skills
Participates in all statistical aspects of a trial/project with minimal 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 and brings to the attention of project leader. Creates timelines for statistical project management with minimal or no assistance.
Contributes to the thought process of endpoint selection and study design. Calculates samples sizes, power calculations, and interim stopping guidelines, with guidance. 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
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 remains abreast of guidelines from the FDA, ICH, EMEA, or other regulatory agency as they apply to statistics and programming. Demonstrates a solid understanding of the clinical drug and/or device development process

Perform other related duties incidental to the work described herein.

Minimum Qualifications

Education

Position requires a minimum of aDoctoral degree in (bio) statistics or related field and no relevant experience, or a Master's degree in (bio) statistics or related field and 2 years relevant experience, or a Bachelor's degree in (bio) statistics or related field and 4 years relevant experience.

Experience

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE Contribution to analysis of clinical trials and/or clinical research projects, and/or participation in preparation of academic manuscripts or other written summaries of analysis results, thorough experience with SAS, and solid command of the English language is required. Desirable experience includes prior role as a lead statistician on clinical trials and/or clinical research projects that have delivered the agreed-upon end products on time, and prior guidance of lower level or less experienced staff.

Duke 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 essentialjob 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.