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BIOSTATISTICIAN III

Requisition Number::  132609
Date:  Aug 28, 2021
Location: 

Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

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.

 

 

Position Description

 

Occupational Summary

Work with the Duke Cancer Institute’s [DCI] Biostatistics Shared Resource as a biostatistician across multiple projects across disease-specific groups as assigned. Specifically, this position will collaborate with DCI members within the Departments of Radiation Oncology and Population Health Sciences by performing intermediate and advanced statistical analysis and programming for clinical research projects.  This biostatistician will be required to manage project responsibilities independently, handle multiple competing projects and deadlines, and coordinate all the statistical needs of each project.

 

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 projects. Identifies potential data problems from analytic queries and takes appropriate initiative to guide the process of resolution. Demonstrates thorough understanding of clinical project data collection processes and data sets and shares knowledge with collaborators, fellow statisticians, and programmers.

 

Guide all statistical aspects of a project without guidance. Collaborate with project leader, principal investigator, other clinical investigators, and external government or industry representatives to affect significant decisions regarding the project, and to jointly achieve objectives and timelines.

Understands the contracted scope of work and forecasts monthly hours expected to complete each 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 project. Independently and proactively assesses how clinical 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 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.

 

Skills

Ability to plan and implement clinical research studies in collaboration with faculty.  Strong communication and technical writing skills.   

 

And other work as assigned.   

 

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities.

 

Preferences

Experience with R and SAS.  Experience with basic descriptive statistics, categorical data analysis, longitudinal data, survival analysis, clinical trial design and analytics, and clinical trial monitoring is strongly preferred.  Experience managing multiple projects. 

 

Qualifications Required At This Level

Education/Training

Position requires a minimum of a Doctoral 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

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/or R, 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. Or an equivalent combination of relevant education and/or experience.

 

 

 

 

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.

 


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh