Associate Director, Statistical Programming

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Purpose

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 define our internal statistical programming environment and processes. 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 will lead one or more Therapeutic Areas (TA) working with the Statistics TA lead to ensure all work required in the TA is completed within the project timelines with high quality.

Responsibilities:

• Working with the Director, Statistical Programming and members of the Clinical Data Standards & Programming leadership to provide the necessary infrastructure and tools to support the development of ADaM datasets, Tables, Figures, Listings (TFLs) and Analysis content.
• Collaborates with the Statistics TA lead and study statisticians to design TA specific standard data structure, ADaM mapping specifications and TFL Shells. Leads and oversees the team’s production and validation efforts for the designed output, this may include oversight of work by CROs.
• Plans and leads 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.
• Plans and leads the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
• Works closely with Director, Statistical Programming to help hire, develop and maintain talented SAS programmers supporting TA needs.
• Plans for and promotes the development of global tools that will increase the efficiency and capacity of the Statistical Programming group.
• Additional tasks:
• Collaborates with CR&D staff with regard to 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

Education

• BSc/MSc/Diploma) 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 10 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
• Preferred 3 or more years of direct supervisory experience.
• 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).
• Knowledge in statistical programming using SAS.
• 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.

Competencies

• Excellent communication and analytical skills.
• Strong interpersonal skills and track record of staff management or effective leadership.
• Strong strategic planning and organizational skills.
• Ability to work successfully in a matrix organizational structure.
• Networking skills and ability to share knowledge and experience amongst colleagues.
• A solutions oriented mindset.
• Presentations of programming techniques at professional conferences is a plus.
• Fluent in English, oral and in writing.

Working Conditions

• Desk job that will include sitting and working on a computer monitor regularly.

Travel Requirements

• International travel about twice a year.