CSL Limited

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Senior Clinical Programmer

at CSL Limited

Posted: 10/20/2019
Job Status: Full Time
Job Reference #: R-101670-1

Job Description

With operations in 35+ nations and ~ 20,000 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!

Responsibilities

Qualifications

Main Responsibilities and Accountabilities:

  • Defines the data collection for clinical studies by creating data definitions in the metadata repository and by using programmatic tools
  • Creates eCRFs in the Medidata Rave EDC systems by implementing defined data collection standards into the study and amend it with study specific customizations and additions
  • Implement edit checks according to CSL’s standard and ensure their usability in studies
  • Supports the definition of metadata for non-eCRF data sources in the metadata repository system to allow automated processing of incoming and outgoing data for all data sources used in clinical studies.
  • Supports the mapping of data collected in eCRFs or eCOA tools into standardized formats following the CDISC standard to enable standardization and data pooling
  • Collaborates in the development of strategies for the integration of non eCRF data in the eCRF database (eg, IRT integration) provides technical support to internal team members as well as to external vendors as requested by study teams
  • Collaborates in the set-up and maintenance of a suite of reports (eg, metadata QC reports, clinical data listings, dashboard reports on operational data)
  • Collaborates with peers, data management, statistics and external service providers to ensure the quality and accuracy of clinical data collected in CSL’ studies. Manages the review of related deliverables with internal teams and external vendors
  • Supports CD staff in any data standards related questions

Qualifications and Experience:

  • 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
  • At least 3 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 including standards metadata management
  • Strong knowledge in CDISC standards (CDASH, SDTM, ADaM)
  • Strong Medidata Rave knowledge in study build, edit check programming
  • Good understanding of the Medidata Rave Core Configuration and Lab Administration
  • Good SAS programming skills
  • 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
  • Good planning and organizational skills
  • Networking skills and ability to share knowledge and experience amongst colleagues
  • Fluent in English, oral and in writing

Capabilities

Worker Type:

Employee

Worker Sub Type:

Regular


With operations in 35+ nations and ~ 20,000 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!

If you are an individual with a disability and need a reasonable accommodation for any part of the 

application process, please click here

CSL is an Equal Opportunity Employer

Privacy Policy

CSL does not accept referrals from employment businesses and/or employment agencies with respect to the vacancies posted on this site.  All employment businesses/agencies are required to contact CSL's human resources department to obtain prior written authorization before referring any candidates to CSL.  The obtaining of prior written authorization from the human resources department is a condition precedent to any agreement (verbal or written) between the employment business/ agency and CSL.  In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of CSL.  CSL shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.



Posted 30+ Days Ago

Full time

R-101670