Principal Stat Programmer

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.

Main Responsibilities and Accountabilities:

• 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.

Additional tasks:

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

Job Qualifications and Experience Requirements:


Education


• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience
• Other degrees and certifications considered if commensurate with related programming experience

Experience

• At least 7 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
• In-depth understanding of clinical programming and/or statistical programming processes and standards.
• In-depth 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.

Competencies


• Excellent Verbal, Written, communication and analytical skills with demonstrated Fluency in English.
• Strong interpersonal skills and effective leadership.
• Strong strategic planning and organizational skills.
• Ability to work successfully in a matrix organizational structure.
• A solutions-oriented mindset.
• Excellent accuracy and attention to detail.
• Networking skills and ability to share knowledge and experience amongst colleagues. Presentations of programming techniques at professional conferences is a plus.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at

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