Associate Director, Statistical Programming

CSL•King of Prussia, PA

30d

About The Position

Position Summary: The Associate Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. The individual will work closely with the Director, Statistical Programming to ensure all assigned Statistical Programming tasks are managed to completion. They will 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. This individual may 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. Main Responsibilities and Accountabilities: Working with the Director, Programming to assess upcoming activities and resulting resource needs and ensure high quality, timely, delivery of assigned projects. Ensure realistic project planning. 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 ad-hoc requests. Mentors programmers allocated to assigned projects and provides feedback to managers of aligned 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. Collaborate with Biometrics and other departments to ensure transition points in process are efficient and of high quality.

Requirements

BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
Other degrees and certifications considered if commensurate with related programming experience
At least 10 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.
Coding in SAS, including SAS macro language
Broad knowledge of clinical development and processes
Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management
Ability to collaboratively work and provide leadership in matrix environment
A solutions oriented mindset
Fluency in technical requirements for CDISC compatible datasets and DDT files

Nice To Haves

Interest and/or experience in expanding beyond SAS as the primary programming delivery tool
Experience in and/or passion for automatization of routine programming tasks
Presentations of programming techniques at professional conferences is a plus

Responsibilities

Working with the Director, Programming to assess upcoming activities and resulting resource needs and ensure high quality, timely, delivery of assigned projects.
Ensure realistic project planning.
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 ad-hoc requests.
Mentors programmers allocated to assigned projects and provides feedback to managers of aligned 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.
Collaborate with Biometrics and other departments to ensure transition points in process are efficient and of high quality.