Senior Statistical Programmer 1
Quantime World PVT LTD · Kochi +1 more, India
Free account: apply link, HR contact and an AI-written cold email
Quantime World PVT LTD · Kochi +1 more, India
Free account: apply link, HR contact and an AI-written cold email
Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research. *SUMMARY: To perform the lead programming role, lead continuous improvement in the programming function’s operating systems and provide consultancy across the function* *RESPONSIBILITIES:* _Some team members may focus on a limited number of these responsibilities depending on requirements. __Tasks may include but are not limited to:_ Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL). Perform review and provide guidance on the development of the clinical database specification, data transfer agreement/specification, specification of tables, figures and listings (TFL) shells. Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL shells and other specifications, e.g. patient profiles, OPS reports. Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide) for high complexity studies. Serve as a programming project lead on a complex study (e.g. adaptive design, integrated safety/efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources and competing project priorities effectively. Ensure budget and scope of project work remain aligned. Manage the study documentation flow as per Worldwide SOP and other procedural documentation including timely document submission to eTMF. Be able to describe and explain Worldwide documentation and eTMF requirements. Contribute to department process improvement including creating and testing standard SAS Macros, maintaining the required validation documentation. Provide consultancy to Clinical Data Managers, Statistical Programmers and Biostatisticians on programming, clinical and analysis data standards (CDISC) and electronic data submission requirements. Develop and provide Statistical Programmers with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer. Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) and other software applications (e.g.
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