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Biostats Specialist - NJ in Berkeley Heights, NJ at Apex Life Sciences

Date Posted: 12/4/2018

Job Snapshot

Job Description

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

  • Work under the direction of Medical Affairs Statistics Disease Lead. 
  • Provide statistical input on study design, sample size, and overall protocol for clinical trials. 
  • Prepare or review statistical analysis plan, including table shells.
  • Review analysis dataset specifications and all deliverables provided by CRO. 
  • Provide statistical support for publications and oral/poster presentations at medical/scientific meetings. This includes conducting ad hoc analyses, interacting with authors, journal referees, and in-house reviewers in the preparation of publications and oral/poster presentations. 
  • Provide statistical reviews of proposed study design and data analysis for investigator initiated trials. 
  • Manage outside CROs and in-house consultants as needed. 
  • Provide statistical support to different functional groups across the company (regulatory, clinical, marketing, data management, health economics, etc.) as needed. 

Skills/Knowledge Required: 

  • Masters in Statistics with a focus on statistical methods appropriate for clinical trials is essential. Ph.D. in statistics preferable. 
  • 5-10 years of experience and demonstrated skill in the planning, analysis and reporting of clinical trials. 
  • Good planning and project management skills. 
  • Detailed knowledge of currently acceptable statistical methodologies. 
  • Excellent SAS skills including report generation. Willingness to be hands-on when needed. 
  • Knowledge of MS Office products (Word, Excel, PowerPoint) 
  • Excellent communication, writing and organizational skills is essential. 
  • Demonstrated ability to work in a team environment with clinicians, 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.