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
- 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
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What We Do
At Alumis, our goal is to significantly improve the lives of patients by replacing broad immunosuppression with targeted therapies. We recognize that patients living with immune-mediated diseases need alternatives to currently available therapies. Despite recent advances and innovations in the treatment of immune-mediated diseases, many patients continue to suffer, cycling through currently approved therapies while looking for a solution that alleviates the debilitating impact of their disease without life-limiting side effects. Addressing the needs of these patients is why we exist. We are pioneering a precision approach that leverages insights we derive from powerful data analytics to select the right target, right molecule, right indication, right patient, and right endpoint resulting in optimized outcomes for patients. We believe that combining our insights with an integrated approach to drug development will produce the next generation of treatments to address immune dysfunction. Incubated by Foresite Labs, Alumis is led by a team of deeply experienced professionals who are devoted to transforming the lives of patients with immune-mediated diseases by developing a pipeline of transformative therapies.
