Job Description

Responsibilities:

Providing statistical programming support to generate tables, listings, and figures for assigned projects.

Demonstrating proficiency in CDISC, SDTM, and ADaM to support various submission activities, including IA, CSR, DSUR, and publications.

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.

Reviewing statistical analysis plans, annotated CRFs, and integrated summaries, providing thoughtful feedback.

Validating datasets and tables through double programming.

Having a good understanding of oncology-specific domains is an advantage.

Requirements:

A master's or bachelor's degree (or equivalent qualification) in a relevant field.

At least 5 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.

Prior experience in oncology and vendor management is highly preferred.

Job Tags

Permanent employment, Shift work,

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