Location: This is a hybrid remote/in-office role.
About the Team:
Reporting to the VP, Statistics and Regulatory Science Innovation, you will provide statistical and medical development expertise to lead customer deliveries or strategic CDRI projects. Project teams may include junior statisticians, statistical programmers, and administrative support.
Responsibilities:
- Strong ability in the design, analysis, and interpretation of clinical trials and clinical research
- Assist in the development and support of innovative approaches to optimize the conduct and science of clinical trials, including use of synthetic control arms.
- Provide statistical expertise including but not limited to research in statistical methods, development of statistical sections of protocols or analysis plans, participation in scientific publication or presentation, and data analyses for individual projects or larger synthetic controls programs. Medidata has access to patient level data from thousands of previous clinical trials in the Medidata Enterprise Data Store (MEDS) which may be the basis for this work.
- Create and review protocols, statistical analysis plans, and other clinical trial related documents.
- Work collaboratively with vendors and other Medidata groups to assist in evaluating the accuracy of standardized historical data for each project assigned
- May present at internal or external meetings or communicate findings through written reports
- Strong statistical skills, particularly in propensity score or other matching or weighting methods and/or Bayesian approaches to clinical trials with an appetite for innovation
- Ability to work in a fast paced environment and work on multiple projects at the same time
- Awareness of regulatory and industry expectations and practices
- Support customer deliveries
- Support and develop CDRI strategic priorities
- Other duties as assigned
Qualifications:
- 6+ years experience as statistician in clinical development with PhD in biostatistics, statistics, or related field
- Alternatively 10+ years experience as statistician in clinical development with Masters degree in biostatistics, statistics, or related field may be considered
- Solid knowledge of typical drug development processes, including for example the regulatory interactions expected at each phase of development and the level of evidence generally required for approval of a new medical product, experience in the oncology therapeutic area is a plus
- Strong organization and leadership abilities
- Excellent written and verbal communication skills
The salary range posted below refers only to positions that will be physically based in New York City. As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. Pay ranges for candidates in locations other than New York City, may differ based on the local market data in that region.
The salary range range for this position physically based in NYC/ NJ Metro Area is $184,600 - $246,000.
Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides benefits, including medical, dental, life and disability insurance, 401(k) matching, family leave, flexible paid time off; and 10 paid holidays per year.
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