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Title:Senior Biostatistician
Salary:Open
Experience:5+
Location:MA - Marlborough

Description:
This position is responsible for biostatistical activities in support of clinical trials including: generating data tables, patient data listings and reports using SAS; preparing statistical analysis plans; contributing to the statistical section of clinical trial protocols; reviewing analysis of clinical trial data.

Responsibilities:
  • Generates statistical summary tables, patient data listings, and reports using SAS.
  • Performs quality control check of SAS programs.
  • Handles complex SAS programming issues as well as all other study programming issues.
  • Works with the Biostatistics Manager and Clinical Sciences staff to develop scientifically sound clinical study designs and contributes to the statistical section of clinical research protocols.
  • Provides input to database requirements and provides SAS dataset specifications for EDC trials. Assists with UAT of data transfer files.
  • Contributes to or prepares statistical analysis plans under the direction of Biostatistics Manager.
  • Prepares template and performs programming for periodic progress reports for assigned clinical programs.
  • Compiles clinical data and relevant background material, and presents these results to the Biostatistics Manager for review.

Requirements:
  • Master's level degree in biostatistics, statistics, or public health; Bachelor's level degree will be considered.
  • At least 5 years of experience in SAS programming; preferably 3 years in medical device or pharmaceutical clinical trials.
  • Demonstrated computer expertise in SAS programming and word processing; experience using SQL and EDC highly desirable.
  • Familiarity with clinical trial design and analysis issues.
  • Ability to think analytically, process scientific and medical data and multi-task.
  • Ability to work and make decisions independently and understand basic medical information.
  • Good organizational, and time management skills.
  • Basic knowledge of regulatory guidelines (FDA/CFR; ENISO14155/GCP/ICH).
  • Ability to work with minimal supervision.
  • Strong interpersonal communication and presentation skills.

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