Capably applies knowledge of statistics to independently generate tables, listings and graphs of clinical trial data. Review statistical deliverables for consistency and scientific integrity. Represents the department during bid meetings and audits and provides line management and statistical advice throughout clinical projects. Serve as technical lead on projects, interacts with clients on statistical issues, provides guidance to other employees on technical issues. Review and write statistical plans and reports.
PRIMARY JOB FUNCTIONS:
Serves as technical lead on projects
Provides statistical consulting internally and to sponsor’s, ensuring methods are appropriate for analyses.
Act as senior statistical reviewer of projects assuring statistical validity and integrity of results.
Serves as core team member for the projects comprising a program, which includes supervising the initiation, planning, and execution of all Biostatistics related tasks awarded to the department per contract as well as monitoring and projecting the operational and financial status of the Biostatistics department's portion of the contract
Works with clinical SAS programmers to ensure the accuracy of summary tables, listings, and graphs produced for final reports.
Writes SAS programs to produce statistical analyses and analysis tables.
Writes analysis plans and statistical reports.
Acts as project manager for stand-alone Biostatistics projects.
Aids in the development of protocols by writing the statistical portion of protocols, providing sample size calculations and reviewing protocols for consistency.
Aid business development with statistical considerations for new study bids, writing bid text, preparing biostatistics budgets, and attending bid defense meetings.
Serve as a mentor to junior level biostatisticians to help develop skills in the Global Biostatistics department.
Develop and maintain overall awareness in the field of biostatistics by reading related literature, attending training classes, professional meetings, statistical conferences etc.
Keep detailed records of time spent on each project to allow accurate billing.
Respect and maintain the confidentiality of the processed material and ensure that any regulations concerning security or confidentiality (such as the safeguarding of passwords) are complied with
Perform other work-related duties as assigned
Advanced degree (MS or PhD, or equivalent) in statistics or closely related field
6-10 years direct experience in clinical trials design and analysis.
Good English communication skills (written and oral)
Ability to effectively communicate with others on the project team and in the department; strong interpersonal communication skills
Detail oriented, well organized
Ability to work on several projects simultaneously
Demonstrated knowledge of design of clinical trials and regulatory requirements
Premier Research - 21 months ago