Principal Programmer

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 ). Supports the review of related deliverables when provided by CROs.

• Leads and oversees requested efforts for pooled and exploratory analyses working
  closely with Statistics TA lead and/or study statisticians as well as with clinical
  programming team and their collection of legacy data.

• Leads and oversees the in-house specification and delivery of ISS and ISE datasets and
  associated output (tables figures and listings) when not provided by CRO

• Leads and oversees the design and implementation of complex SAS programs for
  applications designed to analyze and report complex clinical trial data in CDISC ADaM
  format.

• Leads and oversees the development of global tools that will increase the efficiency and
  capacity of the Statistical Programming group.

• Works closely with clinical study teams to execute activities to ensure project timelines
  are met with high quality deliverables.

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:

• 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 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:

• Excellent communication and analytical skills.
  Strong interpersonal skills and effective leadership.
  Strong strategic planning and organizational skills.
  Ability to work successfully in a matrix organizational structure.
  A solutions-oriented mindset.
  Excellent accuracy and attention to detail.
  Networking skills and ability to share knowledge and experience amongst
  colleagues. Presentations of programming techniques at professional
  conferences is a plus.

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at 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 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 Experience:

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