Remote Contract- Biostatistician Job at SimulStat's client, Georgia

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  • SimulStat's client
  • Georgia

Job Description

12 month remote renewable contract Top 3 Must Have Skill Sets:

  • SAS experience
  • Pharma industry experience
  • Statistical Analysis experience
  • Experience with claims databases (big plus)
Work under the direction of Medical Affairs Statistics Disease Lead.
  • Actively provide statistical support to the Medical Affairs Department.
  • 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 (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.
KNOWLEDGE/SKILLS/ABILITIES (KSA's):
  • Masters in Statistics with a focus on statistical methods appropriate for clinical trials is essential. Ph.D. in statistics preferred.
  • Minimum of 3 years of solid experience and demonstrated skill in the planning, analysis and reporting of clinical trials.
  • Experience with time-to-event data.
  • Good planning and project management skills.
  • Knowledge and curiosity 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.

Job Tags

Contract work, Remote work

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