Senior Clinical Programmer

About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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 Description

• Provides management of clinical and operational data within on one or more studies within a designated Therapeutic Area (TA) or is a team member a function that supports the delivery of the portfolio. Functions supporting this activity includes Data Management, eClinical Operations, R&D Business Support, Clinical Programming as well as Performance Management.
• Executes the overall clinical and operational data for their study. Supports the entire data flow of studies to enable delivery of high-quality, consistent and integrated datasets for regulatory submissions. Where required, supports the broader R&D data strategy through systems and processes.
• Manages a system within the overall eClinical Technology suite of systems for the Therapeutic areas. For the system, translates business needs into the eClinical Roadmap. Implements, maintains and supports eClinical solutions. Configures and integrates eClinical solutions on project and study level. Applies Business Intelligence reporting to enable data driven decisions.
• Ensures all activities that support the TA model are successfully planned, implemented and completed in accordance with the TA strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
• Follows the processes, systems and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards.

Main Responsibilities:

1. Collaborates with the clinical study team in developing ongoing data quality standards and clinical data acceptance rules for clinical data in the eCRF and related external data sources collecting data from clinical studies.

2. Leads the implementation and maintenance of internal data quality control programs, acceptance criteria for data from external sources and performs the related programming.

3. Leads the set-up and maintenance of a suite of reports that function as a sample report library for study teams to choose from in order to help them efficiently lead their projects.

4. Leads the implementation and organization of automated regular reports on study platforms and oversees correct processing of automated reports.

5. Collaborates with peers, data management and statistics to ensure the quality and accuracy thus submission readiness of clinical data as required by authorities (i.e. SDTM, ADaM, define.xml). Supports the review of related deliverables.

6. Leads the development of Data Visualization tools providing information about data quality, study metrics, etc.

7. Performs data storage in a format that allows pooled analyses and exploration of legacy data and ensures a smooth data retrieval processes
8. Additional tasks:

• Supports CR&D staff in any data standards related questions.
• Collaborates in the development of strategies for the integration of non eCRF data in the eCRF database, provides technical support to internal team members as well as to external vendors as requested by study team.
• Leads data exchange with other CR&D groups like e.g. Statistics, Pharmacometrics, Medical Writing & Disclosure etc.
• Perform statistical analyses and SAS programming to:
  • support responses to regulatory agencies,
  • support clinical safety monitoring of safety signals,
  • 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

Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.

Education

Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experience

Other degrees and certifications considered if commensurate with related data management experience

Experience

5+ years experience working in clinical data management, statistical programming or clinical systems within the CRO/pharmaceutical environment.

Understanding of data management and/or statistical programming processes and standards.

Knowledge in statistical programming using the SAS software or reports programming in reporting tools such as Business Objects or J-Review.

Knowledge in CDISC standards (CDASH, SDTM, AdAM)

Ability to work effectively in a team setting, and to meet set goals by managing own timelines

Ability to work in cross-functional, multicultural and international clinical trial teams.

Competencies

Good communication and analytical skills.

Good planning and organizational skills.

Ability to work successfully in a matrix organizational structure.

Networking skills and ability to share knowledge and experience amongst colleagues.

Fluent in English, oral and in writing.