General Information

Location: Bala Cynwyd, PA

Organization: ACI Clinical

Job Type: Full Time - Regular

Description and Requirements

The Biostatistician will be responsible for a range of statistical activities at ACI. Working under the direct supervision of the Director of Biostatistics, performs assigned tasks related both to statistical analyses and statistical programming. The Biostatistician will support the development of SAPs/Charters, Mock shells, Statistical Reports and presentations of the Statistical Analysis Plan and Analysis Results to Data Monitoring Committees. This role will also prepare relevant statistical sections for clinical study reports. 

This position interacts with global project teams that include sponsors, contract research organization (CRO), statisticians, programmers and project managers. Additionally, this position does not have direct reports and works under minimal supervision ensuring adherence to regulatory and company standards.

RESPONSIBILITIES: 
  • Analyzing data, using SAS or other statistical programs
  • Preparing graphs, tables, and listings with ACI in-house macros when appropriate
  • Creating and auditing analysis programs
  • Performing biostatistical analyses under the supervision of more senior staff
  • Calculating sample sizes for clinical studies with standard designs
  • Preparing randomization lists
  • Assisting with writing analysis plans
  • Contributing to IDMC reports under the supervision of more senior staff
  • Drafting minutes and summaries of meetings
  • Creating and maintaining biostatistical documentation, including descriptions of methods, SAS programs and results 
  • Supporting the creation SOPs regarding biostatistical processes 
EDUCATION REQUIREMENTS:
  • Master’s degree (MS) in Statistics, Biostatistics, or a related field with Pharmaceutical industry experience. 
QUALIFICATIONS/EXPERIENCE:
  • Minimum of 2 years experience in clinical trials with statistical software and packages like SAS, R or EAST preferred.
  • Knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, and statistical programming.
  • Attention to detail, accuracy, initiative, and excellent communication skills are essential, as well as the ability to juggle several complex tasks simultaneously.
TRAVEL REQUIREMENTS:  20%