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Title:Biostatistician
Salary:Open
Experience:0-2
Location:NC - Raleigh

Description:
Biostatistician is responsible for the statistical deliverables and/or exploratory analysis of important clinical development consequence for one or more clinical trials under the guidance and supervision of the Clinical Trial Biostatistician or Clinical Program Biostatistician.
Works within a global team and has close interaction with other biostatisticians, statistical programmers, data managers, the Clinical Project Manager (CPM), and the study physician.

Responsibilities:
  • Acts as a key supportive biostatistician for 1 or more clinical trials within a clinical project or across multiple clinical projects.
  • Works very closely, in a supportive role, with the Clinical Trial Biostatistician or Clinical Program Biostatistician. Also works with statistical programmers and other biostatisticians.
  • Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician in the protocol development. Has the opportunity to provide input into the trial design, efficacy and safety parameters and the planned statistical analyses.
  • Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician in responding to the request for the randomization schedule and serves as randomization specialist when randomization schedule is generated internally. Has supervised appropriate interactions with the IVRS vendor.
  • Provides input in the review of the CRF and other data management related documents. Provides input in the evaluation of the quality of the database.
  • Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician in the writing of the Statistical Analysis Plan and the mock TFL shells.
  • Provides input in the preparation of the statistical analyses programs in cooperation with the statistical programmers. Provides input in the validation of selected programs and output of the statistical programmers.
  • Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician to organize data review and TFL review meeting. Provides input in the review of the clinical trial report and the interpretation of the results.
  • Adheres to the company SOPs and working procedures.
  • Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician on the coordination of the statistical activities with CRO statisticians. Communicates accordingly with the CRO. Validates selected statistical output delivered by the CRO.
  • Ensures implementation of the project and Global Biostatistics Department standards.
  • When necessary, attends trial team meetings and collaborates with the trial team to meet the timelines.
  • Biostatistician deemed with sufficient experience may serve as a Clinical Trial Biostatistician as agreed by Head of Global Biostatistics Group.
  • Such other responsibilities and projects that the Company may assign.

Requirements:
  • 0 (with Ph.D.) to 2 (with Master’s Degree) years pharmaceutical industry experience.
  • Understanding of ICH E3, E6, and ICH E9 guidelines and the ability to master these guidelines quickly.
  • Sound knowledge of statistical methodology.
  • Experience in clinical trial related SAS programming.
  • Good written and verbal communication skills in English.
  • Able to work under pressure and be a speedy learner.
  • Able to explain statistics in a non-technical manner to non-statisticians.
  • Able to adapt to change.
  • Proactively interacts with the Clinical Trial Biostatistician or Clinical Program Biostatistician and other clinical trial team members.
  • Able to communicate clear, precise, accurate instructions.
  • Is a keen learner. Shows an active participation toward learning new statistical and pharmaceutical development concepts, and the relevant aspects of the disease area of the related projects.
  • Able to work in a multicultural global environment
  • Able to handle multiple tasks, adapt to changing priorities and deliver results in a timely manner.

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