Associate Principal Statistical Programmer (m/w/d)

The Associate Principal Statistical Programmer will be responsible for review datasets in submission ready standard format (ADaM), tables, figures, listings and submission packages. This individual will provide expertise in the design, development and quality control process for SAS programs used to access, extract, transform, review, analyze and submit clinical data for all requested analyses.

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.
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).
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 plans and executes 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,

Position Qualifications and Experience Requirements:

Education
• BSc in Computer Science, Mathematics, Statistics or related area with relevant experience

Experience

• At least 5+ 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.

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