Statistical Programming Lead

vor 2 Wochen

Opfikon, Zürich, Schweiz CSL Vifor Vollzeit

**Key Responsibilities:**

  • Provide leadership and hands-on support in the development and maintenance of statistical programming capabilities to meet regulatory obligations.
  • Collaborate with study teams to design data structures and specifications for ad hoc and study deliverables, including ADaM datasets, tables, figures, listings, and analysis submission content.
  • Lead production and validation efforts for designed output, including oversight of work by CROs.
  • Ensure the quality and accuracy of clinical data as required by authorities, including SDTM, ADaM, tables, figures, listings, and define.xml.
  • Support the review of related deliverables when provided by CROs.
  • Lead and oversee 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.
  • Develop and implement complex SAS programs for applications designed to analyze and report clinical trial data in CDISC ADaM format.
  • Develop global tools to increase the efficiency and capacity of the Statistical Programming group.
  • Work closely with clinical study teams to execute activities to ensure project timelines are met with high-quality deliverables.

**Additional Responsibilities:**

  • Collaborate with CR&D staff regarding data analysis requests.
  • Perform additional statistical analyses, including support responses to regulatory agencies, generating integrated summaries of safety and efficacy, supporting publications and presentations, supporting planning and reporting of clinical trials, and replicating CRO and CSL statistician analyses for QC.
  • Provide support for in-house and outsourced review of other study documents, including protocol and SAP.

**Requirements:**

  • BSc in Computer Science, Mathematics, Statistics, or related area with relevant experience.
  • At least 8 years of experience in clinical programming and/or statistical programming within the CRO/pharmaceutical environment using SAS Software.
  • In-depth understanding of clinical programming and/or statistical programming processes and standards.
  • In-depth understanding of regulatory requirements relevant to statistical programming, including GCP and ICH.
  • Extensive experience with statistical programming using the SAS software, including development and use of SAS Macros.
  • Advanced knowledge in CDISC standards, including CDASH, SDTM, and ADaM.
  • Proven experience in leading programming activities for pooled and exploratory analyses across multiple clinical studies and submission activities.
  • Proven ability to work effectively both independently and 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.

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