Job Description

Responsibilities:

• Demonstrating proficiency in CDISC, SDTM, and ADaM to support various submission activities, including IA, CSR, DSUR, and publications.
• Providing statistical programming support to generate tables, listings, and figures for assigned projects.
• Overseeing all aspects of statistical programming, working closely with statisticians to ensure timely and accurate delivery of statistical outputs.
• Creating detailed specifications for individual studies and comprehensive summaries.
• Directing and supervising CRO activities related to statistical programming, including the creation and validation of SDTM and ADaM datasets.
• Producing safety tables, efficacy tables, and lab shift tables in accordance with the SAP and mock layouts.
• Validating datasets and tables through double programming.
• Having a good understanding of oncology-specific domains is an advantage.
• Reviewing statistical analysis plans, annotated CRFs, and integrated summaries, providing thoughtful feedback.

Requirements:

• A master's or bachelor's degree (or equivalent qualification) in a relevant field.
• At least 4+ years of solid experience in statistical programming with clinical trial data, particularly using SAS software.
• A strong team player who is open to learning and adopting new methods and technologies, contributing positively to team dynamics.
• A quick learner with a proven history of effective collaboration and teamwork.
• Exceptional communication skills, both written and verbal.
• Demonstrated ability to multitask, prioritize, anticipate potential challenges, and achieve goals within a multidisciplinary team environment.

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