Research Design, Programming, and Collaboration
Participate in most statistical aspects of medical research projects, with consultation or assistance when needed. Represent the functional group in project team meetings and contribute constructively to project discussions. Understand the contracted scope of work and forecast hours and schedule to complete a trial/project.
With appropriate guidance, prepare statistical analysis plans. Independently generate descriptive and basic test statistics, analyze basic data requests and generate statistical modeling results.
Learn new statistical methods as needed and apply new skills to future projects.
Document analyses, create summaries, and present results in written and verbal form to requestors.
Be able 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, with guidance.
Collaborate closely with investigators, sponsors, and other trial leadership to ensure that trial/project results are presented accurately and without bias.
Design analysis data set specifications through writing SAS, S-Plus, Stata, or R code.
Find errors, correct, and validate output and results. Perform complex programming such as data transposition and macros.
Program analysis datasets using SAS or other software, combine multiple raw databases and derive analysis variables accurately. Use complicated SAS procedures and options and program with increasing efficiency. 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. Learns new statistical methods and applies new skills to future projects.
Collaborate effectively with other Biostatisticians and statistical programmers that are supporting projects. Identify potential data problems from analytic data queries and bring them to the attention of the team. Demonstrate understanding of clinical trial/project data collection processes and data sets and share knowledge with collaborators.
Collaborate effectively with a variety of types of individuals, both senior and junior; including programmers, medical personnel, and business representatives. Develop leadership and communication skills and share them with others. 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.
Lead or participate actively in the statistical team responsible for designing and validating analysis data sets, programs, and statistical output products (tables, listings, figures). 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 professional qualities in a variety of settings and through multiple experiences and demonstrate increasing ability to manage project responsibilities across a variety of different projects.
Scientific Writing, Editing, Publication
Draft statistical sections for study synopses and protocols, with guidance of senior Biostatistician or faculty statistician. Generate project randomization sequences and random study drug kit numbers; provide input and review of telephone-based on internet-based randomization system specifications.
Build documentation and organizational skills to effectively return to a trial or manuscript project after long intervals during which other members of the project team made no progress.
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.
Possesses broad programming abilities and shares them with others by consultation and example and maintains programming skills even when delegating many programming tasks to others.
Manage project responsibilities with decreasing levels of supervision or regular support and take the initiative to complete project-specific responsibilities with minimal supervision.
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.
Provide input regarding data collection tools and data correction criteria and procedures. Understand study data and the intricacies of the process through which it is being collected.
Adhere to standard operating procedures (SOPs) of the functional department as they apply to documentation and validation of clinical research statistics.
Understand guidelines from the FDA, ICH, EMEA, NIH, or other regulatory agency as they apply to statistics and programming. Participate in educational initiatives regarding protection of human subjects, as required.
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.
You are responsible for effectively managing your workload, seeking help when needed. You will communicate frequently with your manager and faculty contacts to keep them up-to-date on your projects, work and issues as they arise. You will work closely with your manager to implement departmental & Duke Policy and initiatives.
You will adhere to your core work hours; time off requests will be submitted to your manager per departmental & Duke Policy.
You will know and comply with the regulations, rules and Standard Operating Procedures for your department, DCI, Duke Medical Center, School of Medicine, OncCRU, the Office of Research Administration and the Duke Office of Clinical Research.
You will know and comply with Duke's rules, regulations and responsibilities as noted in The Duke Employee Handbook and on the Duke HR website.
2681 BIOSTATISTICIAN II
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
Work requires a minimum of a Master's degree in (bio)statistics or related field and no relevant experience, or a bachelors degree in (bio)statistics or related field and 2 years relevant experience, or an equivalent combination or relevant education and/or work experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE. Prior contribution to analysis of research projects, a working knowledge of SAS, and solid command of the English language is required.
Strong technical writing skills and multiple and varied prior trial/project experiences desirable. MS in (bio)statistics or related field and no relevant experience, or a BS in (bio)statistics or related field and 2 years relevant experience, or an equivalent combination of relevant education and experience
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.