Senior Statistical Programming Lead; CDISC, SAS

• Provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities

• Work closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards

• Manage a Therapeutic Areas (TA) or programs within or across TAs working with the Statistics TA lead to ensure all work required in the TA is completed within the project timelines with high quality

• Oversee the CRO delivery or manage the in-house programming of data sets, outputs, and DDT files of clinical trials and integrated analysis

• Plans and leads the design and implementation of complex specifications and programs for applications designed to analyze and report complex clinical trial data in CDISC format

• Coordinating the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, response to regulatory requests, or other adhoc requests

• Mentors programmers allocated to assigned projects and provides feedback to managers of these team members as needed

• As a project or program leader ensures compliance with programming process and strategy to facilitate accurate and timely programming

• Test and implement state of the art programming methods and tools to the organization and drive automation of delivery, including AI

Requirements

• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
• At least 9 years of experience in either clinical programming and/or statistical programming within the CRO/pharmaceutical environment using SAS Software
• Comprehensive understanding of clinical programming and/or statistical programming processes and standards
• Advanced Experiences with statistical programming using the SAS software including development and use of SAS Macros
• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM)
• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines
• Experience in working in cross-functional, multicultural and international clinical trial teams.

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Hard Skills

• SAS Software
• SAS Macros
• CDISC standards
• CDASH
• SDTM
• ADaM
• statistical programming
• clinical programming
• data analysis
• programming methods

Soft Skills

• leadership
• mentoring
• teamwork
• communication
• project management
• problem-solving
• time management
• independence
• collaboration
• feedback