The Associate Director /Director of Statistical Programming will lead programming activities for the clinical studies according to the study requirements and timelines.
This position will work collaboratively with study statisticians, cross-functional team, and external CRO to ensure timely and high-quality delivery of programming outputs in compliance with regulatory standards.
Responsibilities include providing oversight and quality assurance of vendor work, offering hands-on programming support, developing and implementing programming strategies for clinical trials, and ensuring efficient data management and analysis.
Essential Job Functions:
Lead and manage SAS programming activities to ensure that they meet timelines, and quality standards.
Oversee the programming work provided by the CRO.
Conduct validation and quality control of CRO deliverables (SDTMs, ADaMs, TLFs, Define Packages, and programming-related documents) to ensure accuracy, consistency, and compliance with regulatory standards.
Provide hands-on programming support for various clinical studies, including study reports, ad hoc/post hoc analyses, exploratory analyses, conference, and publications, DSUR, safety review, regulatory submissions, etc.
Collaborate effectively with study statisticians and CRO to develop programming specifications, analysis datasets, and analysis outputs per requests for internal medical monitoring, CSR, ad-hoc analysis, publication, and submission needs.
Support the development and review of study-related documents, including but not limited to protocols, statistical analysis plans, CRFs, data transfer specification, and those supporting database design and data collection.
Work with study team to generate ongoing outputs that support data review and cleaning and enhance data integrity.
Establish and maintain programming standards, processes, and best practices that ensure consistency and quality across programming deliverables.
Develop or evaluate software tools/utilities and procedures to improve programming efficiency, quality, and cross-functional collaboration.
Qualifications:
Required
Master's degree or higher in statistics, biostatistics, or a related field.
7 + years of experience in statistical programming in the pharmaceutical or biotechnology industry, including experience in clinical trial data analysis and reporting.
Strong proficiency in statistical programming languages, such as SAS or R.
Strong working knowledge of CDISC SDTM and ADaM Implementation Guidelines.
Ability to work independently as well as lead programming teams.
Experience managing and working with CRO.
Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams and external partners.
Associated topics:
biostatistics, data analyst, probability, statistics, c