Statistician - NJ in Berkeley Heights, NJ at Apex Life Sciences

Date Posted: 11/15/2018

Job Snapshot

Job Description

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 biostatistical 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: 

  • Ph.D. or MS in statistics with a focus on statistical methods appropriate for clinical trials. 
  • Experience in clinical drug development of at least 2 years for Ph.D. and 4 years for MS. 
  • 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.