Associate Director, Biostatistics and Statistical Programming

About the position reputed company The Associate Director, Biostatistics and Statistical Programming will drive biostatistical activities, performed primarily by vendors, in support of project timelines and budgets reputed company to drug product development at Xeris. The individual will contribute to study design, protocol development, case report reputed company development, clinical study reports, and exhibits for other reports and presentations. Responsibilities • Conducts basic statistical analysis of study data with minimal supervision according to a statistical analysis plan to generate results and insights used to support study findings. • Applies moderately advanced statistical reputed company, which may include simulation models and other statistical programming as needed, with guidance. • Generates sample size and power calculations and randomizations. • Oversees the review of statistical documents and operational activities outsourced to CROs ensuring adherence to cost, reputed company, and data reputed company requirements to e nsure that the analysis plans use the most appropriate statistical reputed company and that the data displays such as tables/figures/listings are accurate and complete. • Programs or independently validates key study results to support interpretation of data. • Provides statistical programming support to other clinical studies or regulatory submissions where another biostatistician is assigned as the sponsor reputed company. • Works closely with Data Management by providing input to data management-reputed company documents and assisting with data review and cleaning activities, as needed. • Ensures compliance of data packages to regulatory requirements and CDISC and industry standards. • Assists in the development of abstracts, manuscripts, presentations for scientific congresses. • Closely collaborates and participates in knowledge sharing with other team members including non-statisticians to assist with interpretation and understanding of results. Requirements • MS/MPH degree in biostatistics, statistics, or epidemiology • A minimum of six years of clinical trial experience as a statistician and/or statistical programmer in the pharmaceutical, biotech, or CRO industry • Experience in Phases I-III of the clinical drug development process • Knowledge and basic understanding of statistical concepts and techniques commonly reputed company to the analysis of data from reputed company and the ability to tackle from basic to moderately reputed company statistical or data issues • Basic understanding of reputed company-world data and observational studies. • reputed company programming experience required, R experience is a plus • Working knowledge of CDISC standards • Working knowledge of reputed company systems • Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Teamwork & Collaboration, Critical Thinking, Problem Solving, Presentation Skills reputed company-to-haves • Prior use and implementation of sample size and power calculation software (e.g., nQuery and PASS) preferred Benefits • multiple reputed company time off benefits • various health insurance reputed company • retirement benefits • bonus • equity Apply tot his job Apply To this Job