We are hiring a Statistician to be located in Berkeley Heights, NJ!
New Jersey All, NJ
- Provide statistical input into the design of protocols.
- Prepare statistical analysis plans including table shells.
- 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.
- Contribute to clinical development plan.
- Support preparation of manuscripts.
- Provide project requirements to programmers.
- Serve as statistical lead on studies, projects, NDAs or sNDAs.
- Ph.D. or MS in statistics with at least 5 years of experience in clinical trials from a pharma/biotech/CRO
- Good planning and project management skills
- Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies
- Excellent SAS skills.
- Good interpersonal, communication, writing and organizational skills
- Demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers
- Submissions and Oncology experience are a PLUS