Statistical Programmer II

Massachusetts General Hospital (MGH) is the largest research hospital in the United States with an annual research budget of approximately one billion dollars. The mission of MGH Biostatistics is to advance public health and biomedicine through the development and application of quantitative methods. The Biostatistics team includes over 50 faculty and staff who actively collaborate on multidisciplinary research projects across more than 25 Divisions and Departments at MGH and beyond including cancer, cardiology, general internal medicine, global health, neurology, pediatrics, psychiatry, pulmonary and critical care medicine, and surgery.

This position will work on research projects in neurology focusing on amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease, including both clinical trials and observational studies. The central project will be the HEALEY ALS Platform Trial, a multi-site, multi-regimen, adaptive clinical trial. Whereas traditional trials evaluate a single drug and require distinct and lengthy start-up and execution, platform trials use shared infrastructure based on a master protocol to evaluate multiple drugs both simultaneously and sequentially and use specialized statistical models to increase efficiency by sharing placebo data. The HEALEY ALS Platform Trial is testing multiple promising experimental therapeutics in collaboration with regimen partners with a trial design and system for data management and analysis that is supportive of submissions to the FDA.

Specific duties of the Statistical Programmer II include collaborating with clinical investigators under the guidance of senior biostatisticians to:

• Generate reports of study progress, including reports for data and safety monitoring boards, tables listings and figures and assist in the design of these reports

• Develop programs and guide efforts to perform robust data manipulation and error detection to ensure data integrity

• Work with study coordinators to resolve data query issues

• Work together with data management and statistical colleagues to assist with construction and validation of analysis data sets

• Independently develop coding specifications based on study protocols

• Generate custom and/or deidentified datasets for data repositories, ancillary studies, or public distribution.

• Develop and maintain pipelines for logging and maintaining reproducible code

• Collaborate with clinical investigators and biostatisticians in preparation of tables and figures for study manuscripts. Help with manuscript review and validation of data abstraction.

• Advise in the development of case report forms and study databases

• Utilize functional programming and help others optimally implement functions

• Engage in professional development opportunities

Job Requirements:

• BS/BA in Statistics, Computer Science, Data Science, or related field; or, MPH with focus in Biostatistics/Epidemiology

• Three years of professional experience in statistical (SAS) programming and collaborative work in clinical research

• Strong background in statistical programming using SAS

• Deep knowledge of programming concepts

• Advanced ability to identify potential issues in data and in code

• Strong communication skills including proficiency in written and spoken English

• Excellent attention to detail

• Experience with FDA or EMA-regulated trials is a plus