Job Overview :
Provides all biostatistical services to meet the requirements of all Clinipace’s clients, including full-service, Bioinformatics, and other type studies.
Meets all the job duties, responsibilities, and requirements of a Biostatistician in addition to those listed here.
Job Duties and Responsibilities :
Supervisory Responsibilities : May be given some supervisory responsibilities for staff or departmental areas
Job Requirements :
Ability to develop professional presentations for presenting statistical issues and solutions to clients internally. Ability to effectively learn and handle new or unfamiliar statistical methods.
Ability to find needed written resources and interact with other Biostat staff with the needed familiarity. Willingness to share expertise with younger staff members.
Familiarity with Clinipace Functional Areas that Biostatistics interacts with on a regular basis (Proposals, Finance, Clinical Operations, Data Management, Medical Writing), and updates appropriate personnel regarding project scope changes which may impact their areas.
Strong understanding of departmental and company procedures which relate to tasks that are performed routinely : Strong understanding of all departmental SOPs and good understanding of all required company SOPs.
Excellent training and presentation skills : Has the ability to clearly communicate statistical concepts and successfully train and develop staff through coaching and presentations.
Ability to serve as a Project Manager for Bioinformatics studies. Coordinate keeping tasks and project activities in line with agreed timelines and budget.
Develops capability for interacting with regulatory agencies on behalf of sponsor matters. Such capability would include ability to write statistical reports and / or present oral arguments to such agencies.
Has completed GCP training and has strong knowledge of ICH guidelines and other regulatory guidelines related to statistics.
Deep working knowledge of clinical drug development process : In-depth understanding of phases of clinical trials and relevant statistical considerations that apply to Phase I-IV studies and non-inferiority concepts.
Ensures statistical quality : Reviews and monitors quality of statistical tasks and project deliverables provided by statistical project team.
Has a developed expertise in 1-2 therapeutic areas. Excellent broad ranging understanding of statistical methods and issues.
Demonstrates leadership in several areas of statistics.