Main Purpose of the Role

The Principal Statistical Programmer is responsible for providing leadership and hands-on support in the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. The individual will work closely with the Associate Director, Director, and Statistical Programmers to build internal programming tools. This individual, working closely with the study team, will be responsible for review and acceptance of contract research organization (CRO) deliverables which are mainly, but not limited to, datasets in submission ready standard format (ADaM), tables, figures, listings and submission packages. This individual will provide expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses. This individual will collaborate with other departments (eg, Biostatistics, Data Management, Regulatory Operations, Medical Writing, ESP teams) to ensure Standard Operating Procedures are followed and the correct study data are used for all requests. This individual will participate in department and cross functional technology development and process improvement initiatives.

• Collaborates with the study teams to design data structure and specifications for ad hoc and study deliverables including, but not limited to ADaM datasets, Tables, Figures, Listings and Analysis Submission content. Plans and leads the production and validation efforts for the designed output, this may include oversight of work by CROs.
• Collaborates with study teams to ensure the quality and accuracy - thus submission readiness - of clinical data as required by authorities (i.e. SDTM, ADaM, tables, figures, listings, define.xml). Supports the review of related deliverables when provided by CROs.
• Leads and oversees requested efforts for pooled and exploratory analyses working closely with Statistics TA lead and/or study statisticians as well as with clinical programming team and their collection of legacy data.
• Leads and oversees the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
• Leads and oversees the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
• Leads and oversees the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.
• Works closely with clinical study teams to execute activities to ensure project timelines are met with high quality deliverables.

• Collaborates with CR&D staff regarding data analysis requests.
• Performs additional statistical analyses including but not limited to:
  • support responses to regulatory agencies,
  • generate integrated summary of safety and efficacy,
  • support publications and presentations,
  • support planning and reporting of clinical trials via exploratory analyses of available data,
  • replicate CRO and CSL statistician analyses for QC

• Provides support for in-house and outsourced review of other study documents including but not limited to protocol and SAP

• 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 8 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
• Indepth understanding of clinical programming and/or statistical programming processes and standards.
• Indepth understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH).
• Extensive experience with statistical programming using the SAS software including development and use of SAS Macros. Strong programming and problem-solving skills.
• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
• Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities (or equivalent).
• 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.