Associate Director, Biostatistics and Statistical Programming
About the position Overview The Associate Director, Biostatistics and Statistical Programming will drive biostatistical activities, performed primarily by vendors, in support of project timelines and budgets related to drug product development at Xeris. The individual will contribute to study design, protocol development, case report form 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 methods, 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, timeline, and data quality requirements to e nsure that the analysis plans use the most appropriate statistical methods 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 lead. • Works closely with Data Management by providing input to data management-related 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 applied to the analysis of data from clinical trials and the ability to tackle from basic to moderately complex statistical or data issues • Basic understanding of real-world data and observational studies. • SAS programming experience required, R experience is a plus • Working knowledge of CDISC standards • Working knowledge of EDC systems • Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Teamwork & Collaboration, Critical Thinking, Problem Solving, Presentation Skills Nice-to-haves • Prior use and implementation of sample size and power calculation software (e.g., nQuery and PASS) preferred Benefits • multiple paid time off benefits • various health insurance options • retirement benefits • bonus • equity Apply tot his job