Senior Statistical Analyst
Research & Development
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:
Reporting to the Director, Statistical Programming you will leverage your statistical expertise, advanced programming skills and solid experience using industry standards (e.g., SDTM, ADaM) and related processes, to support the statistical team and assist in the development and support of innovative approaches to optimize clinical trials, including synthetic control arms.
Review protocols, statistical analysis plans, and other study related documents to support accurate data mapping and statistical analysis. Review specification for different datasets, SDTM/ADAM. Develop SAS programs to generate/validate variables and datasets.
Work collaboratively with data standardization subject matter experts, statistical programmers and biostatisticians and other Medidata AI groups to assist in evaluating the accuracy of integrated historical data
Perform statistical analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming
Requirements (Education & Experience):
Master’s degree or equivalent, in Statistics, Biostatistics or Mathematics
6+ years of statistical analysis and/or SAS programming experience in the Pharmaceutical & Biotech industry. Experience with additional programming languages a plus.
Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
Regulatory submissions experience utilizing define.xml and other submission documents. Understanding of FDA guidelines.
Strong SAS analysis and reporting skills. Solid experience implementing CDISC Standards (SDTM/ADaM) including writing/reviewing ADaM specifications; programming and validation including efficacy domains. Proficiency in SAS MACRO development.
Ability to research clinical trials in clinicaltrials.gov, Trialtrove, PubMed and other references to explore study characteristics
Excellent written and verbal ability, including the ability to be persuasive to a technical or non-technical audience
Prefer experience with pooled clinical trials data and Integrated analysis (ISS and ISE)
Prefer experience in Oncology trials
Prefer experience with multiple sponsors
As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location.
The salary range for positions that will be physically based in the NYC Metro Area is $114,750-$153,00
The salary range for positions that will be physically based in the California Bay Area is $121,500-$162,000
The salary range for positions that will be physically based in the Boston Metro Area is $113,250-$151,000
The salary range for positions that will be physically based in Texas or Ohio is $101,250-$135,000
The salary range for positions that will be physically based in all other locations within the United States is $102,750-$137,000
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 best-in-class benefits, including medical, dental, life and disability insurance; 401(k) matching; unlimited paid time off; and 10 paid holidays per year.