Main Responsibilities and Accountabilities:
Collaborates with the study teams 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. Plans and leads the production and validation
efforts for the designed output, this may include oversight of work by CROs.
Collaborates with study teams 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.
Additional tasks:
• Collaborates with CR&D staff regarding data analysis requests.
• Performs additional statistical analyses including but not limited to:
o support responses to regulatory agencies,
o generate integrated summary of safety and efficacy,
o support publications and presentations,
o support planning and reporting of clinical trials via exploratory analyses of
available data,
o replicate CRO and CSL statistician analyses for QC
Job Qualifications and Experience Requirements:
Education:
Experience:
At least 8 years of experience in either clinical programming and/or statistical
programming, within the CRO/pharmaceutical environment using SAS
Software.
• Indepth understanding of clinical programming and/or statistical programming
processes and standards.
• Indepth understanding of regulatory requirements relevant to statistical
programming (e.g. GCP, ICH).
• Extensive experience with statistical programming using the SAS software
including development and use of SAS Macros. Strong programming and
problem-solving skills.
• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
• Proven experience in leading programming activities for pooled and
exploratory analyses across multiple clinical studies and submission activities
(or equivalent).
• 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:
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.
