Our client is seeking multiple Statisticians to join their team on a long term contract to be onsite at their Berkeley Heights, NJ location. Individuals with Oncology and ISS experience would be front runners for this role.
Responsibilities will include, but are not limited to, the following:
- Prepare statistical analysis plans (SAP)
- Develop table shells and ADaM specs for phase 2/3 clinical trials
- Analyze and report results of clinical trials. Provide tables, listings and graphs for final study reports.
- Provide statistical input for the preparation of final study reports and other required documents.
- Provide statistical support for integrated reports, submissions preparation, and post-submission activities.
- Provide statistical analysis methods and SAS procedures to programmers
- Ph.D. or MS in Statistics or Biostatistics with a focus on statistical methods appropriate for clinical trials
- Intensive experience in clinical drug development at least 3 years for PhD and 5 years for MS.
- Oncology experience and/or integrated Summary of Safety (ISS) for submission would be a PLUS
- Excellent SAS skills. Hands-on works are required
- Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies
- Good planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel
- Good interpersonal, communication, writing and organizational skills
Sthree US is acting as an Employment Business in relation to this vacancy.