United States - NY, New York
>www.medidata.com. Acorn AI is one of the largest AI companies exclusively dedicated to life sciences. It’s built on Medidata’s platform that includes the industry’s largest structured, standardized and growing clinical trial data repository consisting of 17,000+ trials and 4.5M patients. Our team is composed of over 40 PhD/Masters statisticians, data scientists, analytical product leads, former FDA biostatisticians and computational genomicists. Your Mission: Provide statistical expertise for the development and support of innovative approaches to optimize the conduct and science of clinical trials, including use of synthetic control arms. Leverage your statistical expertise and advanced programming skills to execute, manage and QC customer synthetic control arm projects and further develop innovative approaches to optimize clinical trials. Create and review protocols, statistical analysis plans, and other study related documents. Work with the programming team to support, develop and review specification for different datasets, including SDTM/ADAM. Work collaboratively with data standardization subject matter experts, statistical programmers and biostatisticians and other Acorn AI groups to assist in evaluating the accuracy of integrated historical data Perform, guide statistical programmers, and/or QC statistical analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming Your Competencies: Solid ability in the design, analysis, and interpretation of clinical trials, particularly in propensity score or other matching or weighting methods and/or Bayesian approaches to clinical trials with an appetite for innovation Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data. Regulatory submissions knowledge and experience utilizing define.xml and other submission documents. Understanding of FDA guidelines. Strong SAS skills. Excellent written and verbal ability, including the ability to be persuasive to a technical or non-technical audience Ability to work in a fast paced environment and work on multiple projects at the same time Your Education & Experience: PhD degree or equivalent, in Statistics or Biostatistics, Exceptional candidates with MS degree in Statistics or Biostatistics may be considered 3+ years analyzing and interpreting clinical trials data and/or managing/QCing SAS programming in the Pharmaceutical & Biotech industry. Experience working with and guiding statistical programmers Experience in additional programming languages and/or Oncology trials preferred Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform. Medidata’s solutions have powered over 14,000 clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner. US: Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.