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,