– 12 month remote renewable contract
Top 4 Must Have Skill Sets:
* SAS experience
* Pharma industry experience
* Experience with claims databases
* Statistical Analysis experience
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.
• 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.