Position Title: Senior Biostatistician

Duties & Responsibilities: 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. Collaborates closely with a cross-functional trial/project team, physicians, and external government or industry representatives with regard to statistical aspects of each clinical trial/project. Ensures that work products are generated within specified time frames, which can be driven by medical drug/device development-related deadlines.Demonstrates a comprehensive understanding of the clinical drug and/or device development process. WORK PERFORMED Statistical Analysis Planning, Generation, and Interpretation -Prepares statistical analysis plans with minimal or no guidance -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 -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 -Demonstrates 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 -Serves as a resource for other statisticians about a broad spectrum of analysis methods Programming and Data Set Documentation -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, 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 -Programs efficiently -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 -Maintains programming skills even when delegating many programming tasks to others Contribution to Multi-Center Clinical Trials and/or Clinical Research Projects -Guides all statistical aspects of a trial/project without guidance -Collaborates with project leader, principal investigator, other clinical investigators, and external government or industry representatives -Represents the functional group in project team meetings -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 -Creates timelines for statistical project management without assistance -Contributes to the thought process of endpoint selection and study design -Calculates samples sizes, power calculations, and interim stopping guidelines without guidance -Drafts statistical sections for study synopses and protocols, without guidance -Generates project randomization sequences and random study drug kit numbers; provides input and review of telephone-based or internet-based randomization system specifications -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 -Coordinates and attends Data and Safety Monitoring Board (DSMB) meetings -Handles and secures highly confidential and sensitive analyses and documentation -Supports the preparation of DSMB reports and final statistical and study reports, -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 responsiblefor designing and validating analysis data sets, programs, and statistical output products (tables, listings, figures) -Adheres to standard operating procedures of the functional department -Understands and proactively remains abreast of guidelines from the FDA, ICH, EMEA, IRB, HIPAA,or other regulatory agency -Demonstrates solid understanding of the clinical drug and/or device development process Leadership, Project Management, Communication, and Collaboration -Collaborates effectively and confidently with a variety of types of individuals -Demonstrates consistent ability to manages project responsibilities independently, -Consistently handles multiple competing projects and deadlines -Serves as a resource for less experienced programmers and/or statisticians -Presents information on topicsrelevant to statistics and statistical operations at internal statistics meetings -Takes initiative in constructively in resolving system-wide problems that affect statistics and data management of projects -Serves on DCRI wide committees and initiatives Duke is an Equal Opportunity and Affirmative Action Employer

Position Qualifications: Minimum Qualifications Education Position requires a minimum of a Doctoral degree in (bio) statistics or related field and 0-2 year's relevant experience, or a master's degree in (bio) statistics or related field and 4 years relevant experience, or a bachelor's degree in (bio) statistics or related field and 6 years relevant experience. Experience Experience as a lead statistician on clinical trials and/or clinical research projects that have consistently provided high quality end products on time, and prior supervision and/or guidance of lower level or less experienced employees is required. Thorough experience with SAS and solid command of the English language is required. Strong technical writing skills and multiple and varied prior trial/project experiences desirable. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Salary Range: $82,987/yr minimum

Benefits: http://www.hr.duke.edu/benefits/index.php

Web Site: https://dcri.org/

Application Address: https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=25017&siteid=5172&AReq=40610BR

Contact Email: Toya.Hobbs@duke.edu

Application Deadline: TBD