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Bio-statistician
Ref No.: 18-07469
Location: Berkeley Heights, New Jersey
Position Type:Contract
Start Date / End Date: 06/11/2018 to 06/08/2019
Sunrise System Inc. is currently looking for Bio-statistician in Berkeley Heights, NJ with one of our top client.
Job Title: Bio-statistician
Job Id: 18-07469
Location: Berkeley Heights, NJ 07922
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
Responsibilities will include, but are not limited to
  • Actively provide statistical support to the Clinical R&D Department.
  • Provide statistical input into the design of protocols including preparation of the bio statistical analysis section.
  • Suggest optimal statistical designs that are acceptable by regulators.
  • Prepare statistical analysis plans including table shells.
  • Analyze and report results of clinical trials.
  • Provide tables, listings and graphs for final study reports.
  • Provide ad hoc/data driven analyses as needed
  • 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.
  • Support preparation of manuscripts.
  • Provide project requirements to programmers.
  • Serve as statistical lead on studies as needed
  • Manage outside CROs and consultants as needed.
  • Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups. 
Skills/Knowledge Required
  • This position is to provide statistical support for Clinical Pharmacology studies.
  • Working experience MUST include Phase 1 Clinical Pharmacology studies, PK and PK/PD modeling for at least 3 years, preferably 5 years.
  • Ph.D. or MS in statistics with a focus on statistical methods appropriate for clinical trials.
  • Experience in clinical drug development of at least 5 years for Ph.D. and 7 years for MS.
  • Experience must include Phase 1 Clinical Pharmacology studies, PK and PK/PD modeling.
  • Good planning and project management skills with experience in a pharmaceutical statistical department including direct interaction with clinical personnel.
  • Demonstrated skill in the planning, analysis and reporting of clinical trials.
  • Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies.
  • Excellent SAS skills.
  • Willingness to be hands-on when needed.
  • Knowledge of MS Office products (Word, Excel, PowerPoint)
  • 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.
Contact
Vishal Tejaswi
Desk:732-3725-0312 | Email: vishal.t@sunrisesys.com
Or
Sourabh Agrawal | Lead - Talent Acquisition
Direct: (732) 272 0301| Email: sourabh@sunrisesys.com