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BIOSTATISTICIAN III

Employer
Duke University
Location
Durham, NC

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Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details


diversity employer



BIOSTATISTICIAN III
STATISTICAL CENTER

Occupational Summary

Work with the DCI Biostatistics Shared Resource as a biostatistician across multiple projects across disease-specific groups as assigned. 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 clinical research projects.

Work Performed

Research Design, Programming, and Collaboration

Develops and analyzes a variety of research data using sophisticated statistical methods. Keep abreast of the advanced statistical modeling and computing tools.

Serve 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 R code, finds errors, corrects, and validates output and results. Perform 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.

Guide all statistical aspects of a trial/project without guidance. Collaborate 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.

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.

Contribute to the thought process of endpoint selection and study design. Calculate samples sizes, power calculations, and interim stopping guidelines without guidance or minimal guidance. Draft statistical sections for study synopses and protocols, without guidance or minimal guidance.

Collaborates effectively and confidently with a variety of types of individuals: programmers, statisticians (both junior and senior), medical personnel, senior scientists 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. Lead the statistical team responsible for designing and validating analysis data sets, programs, and statistical output products (tables, listings, figures).

Consistently handles multiple competing projects and deadlines. Present information on topics relevant to statistics and statistical operations at internal statistics meetings. Give oral presentations of key statistical methods, operational issues, study results, or project status at trial or clinical project meetings.

Scientific Writing, Editing, and Publication

Prepare statistical method sections for inclusion in study protocols. Review the design and content of database designs and data edit checks. Develops and validates SAS and other programs to support statistical analyses. Provides interpretations of statistical results, and prepares the relevant statistical sections for study reports. Creates and maintains biostatistical documentation, including descriptions of methods, programs and results. Prepares electronic files using appropriate formats for submission to regulatory agencies. Participates in the development of standardization procedures for statistical functions. Reviews and audits statistical analysis plans, SAS programs, and statistical reports including tables, listings, and figures. Provide guidance to more junior biostatisticians.

Write statistical methods section of manuscripts for publication. Drafts and/or revises quantitative, epidemiologic, and medical sections of manuscripts. Helps estimate budgets for biostatistical support for larger, more involved clinical studies (NIH program project grants, multicenter clinical trials etc.). Monitors data collection, institutes procedures to assure data quality and guarantees study protocols are followed appropriately.

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.

Documents analyses, creates summaries, and presents results in written and verbal form to requestors. Write statistical text for study reports and clinical publications. Prepare methods sections and analysis plans for incorporation in abstracts, manuscripts, grants. Demonstrate 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.

Regulatory, Data Security, and Reproducibility

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. Collaborate closely with investigators, sponsors, and other trial leadership to ensure that trial/project results and conclusions are presented accurately and without bias.

Adhere 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.



Requisition Number
401500931

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
2682 BIOSTATISTICIAN III

Job Family Level
74

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, gender, gender expression, genderidentity, 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 robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.

Education

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

Experience

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCEContribution to analysis of clinical trials and/or clinical researchprojects, and/or participation in preparation of academic manuscripts orother written summaries of analysis results, thorough experience withSAS, and solid command of the English language is required. Desirableexperience includes prior role as a lead statistician on clinical trialsand/or clinical research projects that have delivered the agreed-uponend products on time, and prior guidance of lower level or lessexperienced staff.

Auto req ID

105546BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

PI105961087

Organization

Read our Diversity Profile History

Duke University was created in 1924 by James Buchanan Duke as a memorial to his father, Washington Duke. The Dukes, a Durham family that built a worldwide financial empire in the manufacture of tobacco products and developed electricity production in the Carolinas, long had been interested in Trinity College. Trinity traced its roots to 1838 in nearby Randolph County when local Methodist and Quaker communities opened Union Institute. The school, then named Trinity College, moved to Durham in 1892, where Benjamin Newton Duke served as a primary benefactor and link with the Duke family until his death in 1929. In December 1924, the provisions of indenture by Benjamin’s brother, James B. Duke, created the family philanthropic foundation, The Duke Endowment, which provided for the expansion of Trinity College into Duke University.Duke Campus

As a result of the Duke gift, Trinity underwent both physical and academic expansion. The original Durham campus became known as East Campus when it was rebuilt in stately Georgian architecture. West Campus, Gothic in style and dominated by the soaring 210-foot tower of Duke Chapel, opened in 1930. East Campus served as home of the Woman's College of Duke University until 1972, when the men's and women's undergraduate colleges merged. Both men and women undergraduates now enroll in either the Trinity College of Arts & Sciences or the Pratt School of Engineering. In 1995, East Campus became the home for all first-year students.

Duke maintains a historic affiliation with the United Methodist Church.

Home of the Blue Devils, Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.

Mission Statement

Duke Science"James B. Duke's founding Indenture of Duke University directed the members of the University to 'provide real leadership in the educational world' by choosing individuals of 'outstanding character, ability, and vision' to serve as its officers, trustees and faculty; by carefully selecting students of 'character, determination and application;' and by pursuing those areas of teaching and scholarship that would 'most help to develop our resources, increase our wisdom, and promote human happiness.'

“To these ends, the mission of Duke University is to provide a superior liberal education to undergraduate students, attending not only to their intellectual growth but also to their development as adults committed to high ethical standards and full participation as leaders in their communities; to prepare future members of the learned professions for lives of skilled and ethical service by providing excellent graduate and professional education; to advance the frontiers of knowledge and contribute boldly to the international community of scholarship; to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; to provide wide ranging educational opportunities, on and beyond our campuses, for traditional students, active professionals and life-long learners using the power of information technologies; and to promote a deep appreciation for the range of human difference and potential, a sense of the obligations and rewards of citizenship, and a commitment to learning, freedom and truth.Duke Meeting

 “By pursuing these objectives with vision and integrity, Duke University seeks to engage the mind, elevate the spirit, and stimulate the best effort of all who are associated with the University; to contribute in diverse ways to the local community, the state, the nation and the world; and to attain and maintain a place of real leadership in all that we do.”

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