BIOSTATISTICIAN III, DCRI - Statistics

Location
Durham, NC
Posted
Sep 12, 2017
Institution Type
Four-Year Institution

diversity employer



BIOSTATISTICIAN III, DCRI - Statistics
DCRI - Statistics

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.

WORK PERFORMED

Statistical Analysis Planning, Generation, and Interpretation
# Prepares statistical analysis plans, with minimal or no guidance
# Performs and interprets basic and complex analyses with minimal 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 documentation and organizational skills to effectively return to a manuscript project after long intervals during which no progress was made by other members of the project team
# 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, with minimal or no guidance
# Discusses analytic issues related to other findings within a clinical trial/project
# Understands 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

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
# 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
# Helps less experienced programmers and/or statisticians with programming skills

Contribution to Multi-Center Clinical Trials and/or Clinical Research Projects
# Participates in all statistical aspects of a trial/project with minimal guidance
# Collaborates 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 time lines
# Represents the functional group in project team meetings and contributes constructively to project discussions
# Understands the contracted scope of work and forecasts monthly hours expected to complete each trial/project
# Proactively identifies potential out-of-scope activity and brings to the attention of project leader
# Creates timelines for statistical project management with minimal or no assistance
# Contributes to the thought process of endpoint selection and study design
# Calculates samples sizes, power calculations, and interim stopping guidelines, with guidance
# Drafts statistical sections for study synopses and protocols, with minimal or no guidance of senior or faculty statistician
# 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, with minimal guidance of a senior or faculty statistician, and drafts minutes of each meeting
# Handles and secures highly confidential and sensitive analyses and documentation
# Supports the preparation of DSMB reports and final statistical and study reports, including those intended for regulatory submission, and collaborates with medical writers as needed
# 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 responsible for designing and validating analysis data sets, programs, and statistical output products (tables, listings, figures)
# Adheres to standard operating procedures of the functional department as they apply to documentation and validation of clinical research statistics
# Understands and remains abreast of guidelines from the FDA, ICH, EMEA, or other regulatory agency as they apply to statistics and programming
# Demonstrates a 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: programmers, statisticians (both junior and senior), medical personnel, and representatives within the business community
# Demonstrates leadership and communication skills and shares them with others
# Manages project responsibilities independently
# Takes initiative to complete project-specific responsibilities without supervision
# Demonstrates ability to multi-task
# Serves as a resource for less experienced programmers and/or statisticians
# Presents information on topics relevant to statistics and statistical operations at internal statistics meetings
# Participates constructively in resolving system-wide problems that affect statistics and data management of projects, as appropriate

Requisition Number
401320847

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


Education

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 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 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. 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 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.

Auto req ID

93395BR

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.

PI99377695