The Data Associate (DA) will have a background in statistics, biotechnology, clinical data management, computer science, analytical sciences or related field. The ideal candidate will be well-versed in statistical programming, skills, and techniques to support translational and clinical studies. The DA will have strong writing and verbal communication skills as well as a familiarity with clinical data management, Medidata RAVE, database migrations, and strong programming tool (SAS) experience. The candidate will have an opportunity to participate in ongoing research programs and develop and validate multiple databases. They will work closely with the Executive Scientific Director and other team members to support the goals of the Company.
The candidate will be completely aligned with four fundamental pillars of Landos’ entrepreneurial and efficient corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.
- Statistical programming: Program from scratch as well as update existing programs to perform data management, presentation and analysis. Create Study Data Tabulation Models (SDTM) and Analysis Data Models (ADAM) based on Clinical Data Interchange Standards Consortium (CDISC) for internal and FDA review of trial data. Develop, review, validate, and execute SAS programs to create tables, listings, and figures for Landos studies to support the demonstration of the safety and efficacy of Landos therapeutics as defined in the statistical analysis plan. Create and execute macros. Program database integrations.
- Data accuracy and integrity: Program data cleaning/consistency checking programs to support internal applications for all therapeutic areas. Review data editing and export specifications. Document all programming and validation efforts in accordance with Good Clinical Practices. Create, execute and validate edit check programs. Maintain security of databases and restricted files.
- Review and testing: Program and test data export programs. Perform test transfers to ensure efficient processing of data once received from vendors. Use SDTM guidelines to create and receive transfer datasets. Review and provide input on Statistical Analysis Plans, case report forms, data management plans, and TFL specifications. Participate in user testing of case report forms, databases and other inputs into clinical trial management.
- Quality and standard operating procedures: Generate and maintain standard operating procedures (SOPs) for clinical data programming and research tasks. Ensure compliance to SOPs and standards in conduct of research. Participate in development of QC test plans, conventions, specification documents and processes. Maintain a library of reusable code.
- Teamwork: Work independently and collaboratively in a matrixed environment. Be able to successfully work with other Landos team members and external collaborators in database upkeep and cleaning. Participate in project meetings and conference calls as required. Assist in the efficient operation and monitoring of the clinical trials in the presentation of new tools and techniques.
- Communication and reporting: Keep detailed records of all activities, programming notebook, the Landos laboratory information management system (LIMS), and trial databases. Use and implement source code management software. Create dashboard reports. Archive relevant documentation and deliverables. Provide daily and weekly updates of the Landos research progress and data organization to the Scientific Director, and Landos team. Adhere to project timelines.
- Any new responsibilities or changes in the reporting structure as directed by the Landos leadership.
- Maintains the strictest confidentiality of all activities.
- Team player, engendering credibility and confidence within and outside the company.
- Faithfully performs any other tasks requested directly by the Chairman, President & CEO.
- Act in accordance with Landos’ policies and in complete alignment with the Corporate Culture.