Senior Statistical Programmer

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Accountable for reviewing datasets formatted according to submission standards (ADaM), as well as tables, figures, listings, and submission packages.

• Offer expertise in designing, developing, and ensuring quality control for SAS programs utilized in accessing, extracting, transforming, reviewing, analyzing, and submitting clinical data for all required analyses.

• Collaborate with study teams to create data structures and specifications for ad hoc and study deliverables, including but not limited to ADaM datasets, tables, figures, listings, and analysis submission content.

• Work with study teams to guarantee the quality and accuracy of clinical data, ensuring it is ready for submission as mandated by regulatory authorities (i.e., SDTM, ADaM, tables, figures, listings, define.xml).

• Lead and manage efforts for pooled and exploratory analyses, closely coordinating with the Statistics TA lead and/or study statisticians, as well as the clinical programming team and their legacy data collection.

• Direct and oversee the in-house specification and provision of ISS and ISE datasets and related outputs (tables, figures, listings) when not supplied by CRO.

• Spearhead the design and execution of intricate SAS programs for applications aimed at analyzing and reporting complex clinical trial data in CDISC ADaM format.

• Guide the development of global tools aimed at enhancing the efficiency and capacity of the Statistical Programming group.

• Collaborate closely with clinical study teams to strategize and implement activities ensuring project timelines are adhered to with high-quality deliverables.

• Partner with CR&D staff concerning data analysis requests.

• Conduct additional statistical analyses, including but not limited to supporting responses to regulatory agencies, generating integrated summaries of safety and efficacy, assisting with publications and presentations, and supporting the planning and reporting of clinical trials through exploratory analyses of available data.

⛳️ Requirements

• Bachelor's degree in Computer Science, Mathematics, Statistics, or a related field, with pertinent experience.

• Minimum of 5+ years of experience in clinical programming and/or statistical programming within the CRO/pharmaceutical sector using SAS Software.

• Comprehensive understanding of clinical and statistical programming processes and standards.

• Extensive experience in statistical programming with SAS software, including the development and application of SAS Macros.

• Strong programming abilities and problem-solving skills.

• Experience in R programming, either through training or hands-on application.

• Advanced knowledge of CDISC standards (CDASH, SDTM, ADaM).

• Demonstrated experience in leading programming efforts for pooled and exploratory analyses across multiple clinical studies and submission activities.

• Proven capability to work effectively both independently and within a team environment, managing timelines to achieve set goals.

• Experience collaborating within cross-functional, multicultural, and international clinical trial teams.

🏝️ Benefits

• Collaborate with industry leaders on projects that are at the forefront of clinical innovation.

• Gain exposure to a diverse range of therapeutic areas, indications, and phases.

• Opportunities for career development as we expand.

• AI-powered career advancement through our internal talent marketplace.

• Mentorship opportunities across the organization via Employee Resource Groups.

• Flexible working arrangements to support work-life balance and professional success.