| Job Description : |
Responsibilities:
Oversee statistical programming, analysis, and reporting activities for Phase I-IV clinical studies, integrated databases and analyses, safety reviews and ad-hoc analyses
Supervise Statistical and Data Programming staff, with all incumbent supervisory responsibilities
Establish staff competency requirements and training programs
Mentor staff and aid in their development and achievement of competency standards
Standardize, improve, and develop SOPs for data analysis and reporting processes.
Prepare statistical analysis plans for single projects, integrated summaries of safety, and integrated summaries of efficacy
Approve case report form design, data management plans, and edit specifications
Prepare statistical sections of protocols, including sample size calculations; develop randomization specifications and verify randomization codes for basic and complex clinical trials; prepare and annotate shell data displays, perform validation and quality control of complex data displays, write statistical reports and statistical section of clinical study reports
Support project teams on achieving client satisfaction through delivery of quality data, on-time and on-budget
Ensure revenue and operating margin performance of the data management group to agreed targets
Review literature and research technologies/procedures for improving statistics and programming practices
Support business development and marketing activities at client presentations and professional seminars
Participate in proposal development and defense processes
Establish and maintain strategic client relationships
Requirements:
Experience overseeing projects that include Safety, Regulatory, and Site Operation components, in addition to Data Management and Biostatistics, highly desired
PhD, or relative work experience in related discipline, preferred
Broad knowledge and superior understanding of advanced statistical concepts and techniques
Advanced SAS programming knowledge and proficiency with other statistical packages and sample size calculation software
Familiarity with EDC systems
Expert knowledge of clinical data standards and data flows as well as industry standards for submission of data
Experience overseeing projects that include safety, regulatory, and site operation components, in addition to data management and biostatistics
Client management experience
Excellent oral and written English and good presentation skills
Knowledge of the drug development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical and medical device business.
Proven ability to plan and manage capital and operating budgets, as well as plan and advocate staffing resources
Recommended Skills
Biostatistics Biotechnology Business Development Calculations Case Report Forms Clinical Study Reports
Job Snapshot
Employee Type
Full-Time
Location
Bethesda, MD
Job Type
Information Technology
Experience
Not Specified
Date Posted
02/09/2022
Job ID
440/159/828 |
