Position Purpose

In this role the incumbent supports interface departments, e.g., Biostats, Data Management with the (SAS) programming of requests, following standard procedures and work practices to ensure quality control and accurate versioning of analyses that are appropriate for regulatory submissions and publications.
The development of programming scripts for data retrieval, transformation and representation as well as their validation will be the main focus of this role.
The role leads the development and maintenance of data quality standards and performs the necessary programming and validation steps to ensure that regular and on-demand data quality control can be performed in clinical studies. The role will support the clinical study team with the identification, specification, and implementation of relevant listings and reports to ensure that adequate data quality will be achieved for clinical trials. Furthermore, the role will lead the development and implementation of programs to ensure the quality of data deliveries as they are provided by contract research organizations. These are mainly but not limited to eCRF raw data, datasets in submission ready standard format (SDTM, ADaM), and data from external sources as they have been collected in clinical trials (e.g., IxRS systems, eDiary, central laboratory, central ECG) and their related documentation.

Main Responsibilities and Accountabilities

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 statistical analyses for QC

Position Qualifications and Experience Requirements

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

At least 5 years of experience in either clinical data management and/or statistical programming, 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