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Statistician - NJ
Ref No.: 18-01092
Location: Berkeley Heights, New Jersey
Position Type:Contract
Start Date / End Date: 06/04/2018 to 06/03/2019
Actual Job Title = Statistician
Duration = One Year from Start Date
Location = Berkeley Heights, NJ
Typical Daily Work Hours = 830am to 5pm (some flexibility in start/end times) (40 hrs/wk)
Weekend & OT work is not required.
100% onsite work.
Looking for candidates that can start right away.
Job#: JP00006241

Responsibilities will include, but are not limited to, the following:

1. Provide statistical input into the design of protocols including preparation of the biostatistical analysis section. Suggest optimal statistical designs that are acceptable by regulators
2. Prepare statistical analysis plans including table shells.
3. Analyze and report results of clinical trials. Provide tables, listings and graphs for final study reports. Provide ad hoc / data driven analyses.
4. Provide statistical input for the preparation of final study reports and other required documents.
5. Provide statistical support for integrated reports, submissions preparation, and post-submission activities.
6. Contribute to clinical development plan
7. Support preparation of manuscripts
8. Provide project requirements to programmers
9. Serve as statistical lead on studies, projects, NDAs or sNDAs

Skills / Knowledge Required:

1. Ph.D. or MS in statistics with a focus on statistical methods appropriate for clinical trials
2. Intensive experience in clinical drug development at least 5 years for Ph.D and 7 years for MS. Flexbility in years of experience within a few years will be considered.
3. Good planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel
4. Demonstrated skill in the analysis and reporting of clinical trials
5. Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies
6. Excellent SAS skills. Hands-on works are needed
7. Knowledge of MS office products (Word, Excel, PowerPoint)
8. Good interpersonal, communication, writing and organizational skills
9. Demonstrated ability to work in a team environment with medical personnel, clinical monitors, data managers, programmers and medical writers
10. Submission experience is a PLUS
11. Oncology experience would be a PLUS