Sr. Biostatistical Analyst/SAS Programmer (Clinical Trials, CDSIC, STDM & ADaM (open to remote workers))
Leverage your statistical expertise, advanced programming skills and solid ADaM and SDTM experience, 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 Acorn 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
Your 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). Proficiency in SAS MACRO development.
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
Experience with ISS and ISE
Experience in Oncology trials a plus
Experience with multiple sponsors a plus
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 Solutions have powered over 17,000+ 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.
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.