This position in Duke Cancer Institute Biostatistics supports the activities of Alliance for Clinical Trials in Oncology (Alliance), a member of the National Clinical Trials Network. Statisticians in this group work within the Alliance Statistics and Data Center (SDC) and collaborate directly with Alliance Committee members, Ph.D. and master's level statisticians, and others on clinical and translational science studies. Among other activities, they assist in monitoring ongoing clinical trials, perform intermediate and advanced statistical analysis of trial data, provide statistical considerations for concepts and protocols, write statistical study summaries, and assist in manuscript preparation and other presentations of results. The individual in this position will be assigned to the Alliance Respiratory and Leukemia Committees. Under the guidance of a Ph.D. statistician and Senior Biostatisticians, they will effectively manage multiple competing studies and coordinate all statistical aspects of each project to successfully meet deadlines.
Committee meetings (2.5%)
- Attend Alliance Committee and other Alliance study or NCI-related meetings and teleconferences.
- Represent the Alliance SDC in study team meetings and contribute constructively to project discussions.
Concept Development (2.5%)
- Participate in Committee discussion of new concepts and studies.
- Support the Ph.D. statistician in preparing statistical method sections for sub-studies included in concepts.
- Under the guidance of a Ph.D. statistician or Senior Biostatistician, assist in the preparation of statistical and database management sections of NIH grant applications and other externally supported proposals prior to submission.
Protocol Development (5%)
- Participate in the determination of analysis data set specifications and provide input on those prepared by statistical programmer analysts. Participate in the design and content of database forms and data edit checks (MediData Rave) as needed.
- Under the guidance of a Ph.D. or Senior Biostatistician, take part in the development and selection of study-appropriate statistical methods and tests, e.g., simulation studies, novel methods, advanced packages in R.
Trial monitoring (25%)
- Manage all statistical aspects of an ongoing trial with guidance.
- Collaborate effectively with data managers and statistical programmer analysts that support clinical trials.
- Monitor data capture, institute procedures to assure data quality and ensure that study protocols are being followed appropriately. Identify potential data problems from analytic queries and takes appropriate initiative to guide the process of resolution.
- Prepare regulatory reports, e.g., for the Central Institutional Review Board (CIRB), the Alliance Data Safety and Monitoring Board (DSMB), Alliance SDC statistical study summaries. Handle and secure highly confidential and sensitive analyses and documentation such as the preparation of DSMB confidential monitoring reports.
- Work with the statistical team responsible for designing and validating analysis data sets, programs, and statistical output (tables, listings, figures). Develop and validate SAS and other programs to support study statistical analyses.
- Collaborate with project leaders, study chairs, principal investigators, other clinical investigators, and external government or industry representatives to affect significant decisions regarding the trial and to jointly achieve objectives and timelines.
Data cleaning (15%)
- Demonstrate good understanding of clinical trial and study data collection processes and data sets. Share knowledge with collaborators, fellow statisticians, and programmers to promote high data quality.
- Program using statistical software (e.g., SAS; R) and manage electronic computer files.
- Write own SAS or R code, find errors, correct, and validate output and results.
- Perform programming tasks efficiently, use advanced SAS procedures and options. Program analysis datasets using SAS or review those programmed by others to quality of output; combine multiple disparate raw databases and derives analysis variables accurately.
- Consider alternative programming approaches to improve quality and efficiency.
- Possess programming capabilities and share them with others by consultation and example. Maintain and continue to develop programming skills.
Final data analysis (15%)
- Conduct statistical analyses and provide interpretation of results.
- With guidance, analyze a variety of clinical trials research data using basic and advanced statistical methods.
- Perform and interpret basic and more advanced analyses with guidance.
- Use statistical and medical understanding to propose and perform additional analyses appropriately with guidance.
- Conduct secondary analyses and analyses of trial companion studies.
- Collaborate closely with Ph.D. statisticians, Senior Biostatisticians, investigators, sponsors, and other trial leadership to ensure that study results and conclusions are presented accurately and without bias.
- Prepare all relevant statistical sections for study reports. Assist in preparation of statistical methods sections for incorporation into abstracts, manuscripts, grants.
- Create and maintain data files and documentation of data analyses including descriptions of methods, programs, and results.
- Facilitate data sharing by preparation or oversight submission of electronic files to regulatory agencies or other entities using appropriate formats and data sharing processes.
- Adhere to Duke, Alliance, and Alliance SDC Policies and Procedures. Follow standard operating procedures as they apply to documentation and validation of clinical research statistics. Monitor own work compliance with required standards.
- Demonstrate solid understanding of the clinical drug or device development process.
- Understand and proactively remain abreast of guidelines from the FDA, ICH, EMEA, IRB, HIPAA, or other regulatory agencies as they apply to statistics, programming, and handling of clinical data.
- Participate on internal subcommittees and working groups.
- Assist in setting workload priorities.
Professional Development (2.5%)
- Keep abreast of the latest statistical methods and computing tools.
- Learn new statistical methods and apply new skills to future projects.
- Evaluate new statistical methods for data analysis.
- Gain or enhance abilities to write concept and protocol Statistical Considerations.
- Gain knowledge in disease area.
- Strive to work independently.
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.
2681 BIOSTATISTICIAN II
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual'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 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.
Work requires a minimum of a Master's degree in (bio)statistics orrelated field and no relevant experience, or a bachelors degree in (bio)statistics or related field and 2 years relevant experience, or anequivalent combination or relevant education and/or work experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCEPrior contribution to analysis of research projects, a working knowledgeof SAS, and solid command of the English language is required.
Solid command of the English language with strong oral and written communication skills is required.
Proficiency with SAS/SAS graphics or R/R graphics is required; R graphics preferred.
Background in some or all of the following is preferred: basic descriptive statistics and analytic methods, survival analysis, categorical data analysis, longitudinal data analysis, biomarker validation methodology.
Background in clinical trials design, monitoring and analysis is desirable.
Auto req ID
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.