Data Systems & Clinical Programming Specialist (Contractor)
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.
The Data Systems & Clinical Programming Specialist (Contractor) will be responsible to support Data Management (DM) as part of the Clinical Programming function in a rapidly evolving environment, in accordance with industry standards. This role will support Data Systems and Clinical Programming activities and deliverables across programs as directed by the Director and Associate Director, DS&CP.
Essential Responsibilities
Support development and production operation activities within the Data Systems and Clinical Programming function
Maintain Smartsheet trackers for report requests, Production reports, and other DS&CP operational documentation
Participate in the development of report specifications for SAS Clinical Programming reports, and other custom reports/outputs as needed
Review programmed reports/outputs for accuracy against requirements and provided specifications
Provide/transfer source files for reports and dashboards and ensure automated transfers have completed successfully
Transfer programmed reports/outputs to appropriate locations for cross-functional team use
Support requests for new/updated Automated Transfer Service (ATS) vendors and jobs and investigate issues or trigger jobs manually as needed
Provide user access for DM tools
Support Alumis' standard CRFs and standard edit checks initiatives
Participate in EDC, IRT, and eCOA User Acceptance Testing (UAT)
Ensure DS&CP study-specific documentation is in an inspection-ready
Support DS&CP in cross-functional meetings, as applicable
Ensure DS&CP project deliverables are completed on time and in accordance with quality standards and regulatory requirements
Ensure compliance with all relevant data privacy regulations and maintain the security of clinical trial data
Qualifications
5+ years of relevant experience and has earned a BS or equivalent degree
2+ years of experience with clinical trials and data management
Understanding of the programming development life cycle
Knowledge and experience in EDC
Experience with SAS, SQL, and/or other clinical programming tools
Experience working and effectively communicating with global programming teams preferred
Experience with CDISC standards (CDASH, SDTM) preferred
Strong interpersonal, organizational, and communication (oral and written) skills
Logical thinking, attention to detail and accuracy, strong organizational skills, and problem-solving abilities
Ability to prioritize and to adapt quickly to changing business conditions with a "can-do" attitude