Serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed
Review and ensure high quality of Define packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trial(s)
Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning
Provide technical leadership for regulatory submissions.
Manage vendor relationships and internal SOPs.
Genetix Biotherapeutics is pursuing curative gene therapies to give patients and their families more days. They embrace innovation and achieve results through cooperation and the integration of multiple viewpoints, with a focus on radical care.
Responsible for supporting the Programming deliveries of a clinical study or project.
Implements statistical programming aspects of the protocol and the clinical development program.
Ensures high quality is built into own deliverables and the quality delivered by other programmers.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific and focus on quality, professional development, and a supportive culture.
Act as the statistical lead for one or multiple projects.
Provide expert biostatistics input on development plans and study design.
Oversee the vendor/CRO biostatistics teams.
Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of inflammatory and immunology indications. They are a fast-paced company committed to building an exceptional company culture, founded on their C.O.R.E. values.