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Clinical Biostatistician (onsite New Jersey) (Science & Biotech)
Berkeley Heights, NJ 07922
Recruited by: Ali Henderson | Senior Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: SimulStat's client
  • Industry: Science & Biotech
  • Compensation: Depends On Experience
  • Expires: Nov 02, 2019
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Job Description

- 9 month potentially renewable contract
- Onsite NJ


• Responsibilities will include analysis of clinical trial data with emphasis on translational data in addition to analysis of clinical, quality of life and of real world data.
• Work under the direction of Medical Affairs Statistics Disease Lead.
• Actively provide statistical support in the Medical Affairs Department, with emphasis on support of translational research.
• Actively provide statistical support to the Medical Affairs Department.
• This position could support combined analysis of data from multiple clinical trials.
• Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes meta-analysis, multivariate analysis, use of graphical R and SAS tools and support for hypothesis -driven as well as exploratory analyses.
• Interact with authors, referees and in-house reviewers in the preparation of publications, presentation and posters.
• Provide statistical reviews of proposed design and analysis of protocols for investigator initiated trials.
• Provide statistical input for design, sample size and protocol for Medical Affairs studies.
• Provide review of statistical analysis plan including table shells, analysis dataset specifications and all deliverables for Medical Affairs studies provided by CRO.
• Manage outside CROs and consultants as needed.
• Support regulatory responses using Medical affairs interventional and registry data.
• Work closely with different departments in the company (translational, regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.


• Masters or Ph.D. in Statistics with a focus on statistical methods appropriate for clinical trials is essential.
• Minimum of 3 years of solid experience and demonstrated skill in the planning, analysis and reporting of clinical trials.
• Able to analyze clinical trial data with emphasis on translational data in addition to analysis of clinical, quality of life and of real world data.
• A track record of working in pharmaceutical clinical trials with clinical teams.
• Experience with time-to-event data.
• Good planning and project management skills.
• Knowledge and curiosity of currently acceptable statistical methodologies.
• Excellent SAS skills. Strong R skills preferable. 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.