Senior Statistical Programmer

As a Senior Statistical Programmer at Tech Observer, a global Clinical Research Organization (CRO) and Functional Service Provider (FSP), your role will involve the following key responsibilities: - Ensure compliance with working SOPs, Quality Management System, and Good Clinical Practice (GCP), while adhering to programming guidelines. - Implement and follow the latest versions of CDISC, FDA Guidelines, GCP, and other industry standards. - Participate in and co-ordinate the Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures, and study-related documentation. - Review and interpret Report and Analysis Plans, providing comments for assigned projects. - Develop and review SAS programs for managing clinical trial data, tabulating data, preparing patient data listings, and creating derived datasets as specified in the Statistical or Report Analysis Plans. - Design SAS programs for ad hoc tables and listings, supporting Data Management. - Carry out electronic data transfers and review programs to ensure data transfer compliance. - Set up utilities/SAS based systems to facilitate Clinical Data Management activities. - Review draft and final production runs for quality and consistency. - Provide feedback for continuous improvement of SOPs and cross-functional SOPs. - Ensure quality of personal work and team work when acting as a Lead Programmer or Biometrics Project Manager. - Represent Statistical Programming at internal project team meetings, client meetings, and audits. - Support senior Statistical Programming staff activities by providing input into time and cost estimates and client presentations with sufficient experience. - Advise Senior Statistical Programming staff on project scope changes for timely development of change orders. - Demonstrate problem-solving skills, proactive approach, and willingness to make decisions regularly. - Encourage and participate in ongoing process review for continuous improvement. - Stay updated on new programming techniques and IT developments applicable to clinical trial data management and reporting. - Perform other duties as assigned by senior Statistical Programming staff. Tech Observer is a global Clinical Research Organization (CRO) and Functional Service Provider (FSP) with headquarters in New Jersey, USA, and a strong presence in various countries including India, Singapore, the UK, and Denmark.,