HiringCafe
Posted 1d ago

Senior Programmer (Clinical Study)

@ CSL
View All Jobs
King of Prussia or Waltham or Opfikon
OnsiteFull Time
Responsibilities:design data, lead outputs, collaborate teams
Requirements Summary:5+ years of clinical/statistical programming with SAS;/CDISC (SDTM/ADaM); CDASH; ability to work in cross-functional teams.
Technical Tools Mentioned:SAS, CDISC, ADaM, SDTM
Save
Mark Applied
Hide Job
Report & Hide
Job Description

Main Responsibilities and Accountabilities:

  • Collaborates with the study statistician 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. Leads the production and validation efforts for the designed output, this may include oversight of work by CROs.
  • Collaborates with peers and statisticians 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 requested efforts for pooled and exploratory analyses working closely with clinical programming team and their collection of legacy data.
  • Leads the in-house specification and delivery of ISS and ISE datasets and associated output (tables, figures and listings) when not provided by CRO.
  • Leads the design and implementation of complex SAS programs for applications designed to analyze and report complex clinical trial data in CDISC ADaM format.
  • Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group.
  • Works closely with clinical study teams to ensure that project timelines are met with high quality deliverables.
     

Additional tasks

Supports CR&D staff in 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 5 years of experience in either clinical programming and/or statistical programming, within the CRO/pharmaceutical environment using SAS Software.
• Understanding of clinical programming and/or statistical programming processes and standards.
• Experiences with statistical programming using the SAS software including development and use of SAS Macros.
• 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.

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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

 

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

 

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

 

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.