Senior Director of Statistics
United States - NY, New York
Medidata: Power Smarter Treatments and Healthier People
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,900+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @medidata.
Medidata is looking for individuals who will help us tackle some of the most complex questions facing the industry today using our proprietary platform and advanced analytics. At Medidata, we never work alone. This role will partner heavily with all of the key stakeholder functions including product, delivery, data science, engineering, partnerships, and biostatistics. Successful Medidata AI candidates will be skilled in analytical/quantitative thinking, structured communication, and excited about building the next horizon of Medidata’s mission to power smarter treatments and healthier people.
Who we’re looking for:
Assist in the development and support of innovative approaches to optimize the conduct and science of clinical trials, especially concerning the use of Synthetic Control Arms (SCA). An SCA is an external control created using appropriate statistical methods to achieve baseline balance and to augment clinical trials with patient level data from previous clinical trials. Medidata has access to thousands of previous clinical trials available in the Medidata Enterprise Data Store which may be the basis of this work.
Provide statistical expertise in carrying out customer SCA projects in the regulatory and nonregulatory setting, including development of SCA statistical analysis plans, assessment of the adequacy of the available historical clinical trials data to fulfill the SCA research objective, guiding the standardization of data assets and overseeing statistical model building, selection generation of comparative analyses in the interpretation and QC of SCA data analyses and overall conclusions.
Provide statistical expertise including but not limited to research in statistical methods, participation in scientific publication or presentation, and case study data analyses to support the overall SCA program.
Work collaboratively with members of the data standardization team, statistical programming and other Acorn AI groups to assist in carrying out SCA projects.
May present at internal or external meetings or communicate findings through written reports.
Requirements (Education & Experience):
Typically requires a PhD in Biostatistics or Statistics with approximately 10 to 15 years of related experience in the pharmaceutical industry and/or regulatory (e.g. FDA) context analyzing and interpreting clinical trials data
Regulatory submissions experience. Awareness 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 Phase II/III oncology therapeutic area is a plus
Strong ability in the design, analysis, and interpretation of clinical trials and clinical research
Strong statistical and analytical skills, particularly in time-to-event analyses, propensity score or other matching or weighting methods and/or Bayesian approaches to clinical trials with an appetite for innovation
Excellent written and verbal ability, including the ability to be persuasive to a technical or non-technical audience
Ability to work independently in a fast paced environment and work on multiple projects at the same time
Ability to manage and oversee outsourced staff and works
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 base salary pay range for this position is $184,000 to $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 under the terms of applicable plan documents, while many of Medidata’s non-sales positions are eligible for annual bonuses. Additionally, Medidata provides best-in-class Benefits. We believe that benefits should connect you to the support you need when it matters most and should help you care for those who matter most. For that reason, we provide an array of options to help support you physically, financially and emotionally through the big milestones and in your everyday life.