Senior Statistical Programmer

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

📋 Description

• Oversee one or more clinical trials in the capacity of a Senior Statistical Programmer.

• Create, uphold, and verify annotated Case Report Forms (aCRFs).

• Design, maintain, and ensure the accuracy of specifications and statistical programming for SDTM datasets, ADaM datasets, or derived datasets, along with Tables, Listings, and Figures (TLFs), and submission packages.

• Assist in the preparation of deliverables for Data Monitoring Committee meetings, Interim Analyses, and Clinical Study Reports.

• Evaluate and contribute to Statistical Analysis Plans, TLF Shells, and Data Management documents, including eCRFs and edit checks.

• Facilitate data cleaning processes through programming, reporting, reviewing, and resolving statistical data issues.

• Create and validate SDTM and ADaM define.XML/PDF files and reviewer guides.

• Validate SDTMs, ADaMs, and define.XMLs utilizing Pinnacle 21.

• Employ global SAS macros and engage in initiatives aimed at enhancing programming efficiency and quality.

• Serve as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and Interim Analyses.

• Collaborate with Biostatistical study teams and various departments to produce high-quality results within set timelines and budgets.

• Provide mentorship to junior Statistical Programmers as required.

• Stay updated with industry standards and guidance from CDISC, ICH, and regulatory bodies.

⛳️ Requirements

• Bachelor’s degree in Statistics, Computing Sciences, or a related discipline; a master’s degree is a plus.

• Minimum of 5 years of experience in clinical research within the biotechnology, pharmaceutical, or Contract Research Organization (CRO) sectors, including 4 years of Statistical Programming and 1 year in a Lead Statistical Programmer role.

• Strong familiarity with clinical trial data, SAP, TLF Shells, and specifications.

• Proficient in SAS; SAS certification is advantageous.

• Understanding of XML programming is beneficial.

• Comprehensive knowledge of CDISC standards and guidelines; CDISC certification is a plus.

• In-depth knowledge of the drug development process, ICH guidelines (including but not limited to ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, electronic data submission requirements, and Pharmaceutical Industry GPP.

• Highly organized and detail-oriented, demonstrating effective project planning and time management abilities.

• Capability to thrive in a fast-paced environment with a proven ability to manage and prioritize multiple competing demands.

• Must be able to work independently as well as collaboratively in a team setting.

• Strong verbal and written communication skills in English; proficiency in French is an asset.

• Must possess legal authorization to work in South Africa.

🏝️ Benefits

• Permanent full-time position.

• Flexible working schedule.

• Home-based work opportunity.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.

• Commitment to equitable treatment and equal opportunity.

• Recruitment and selection accommodations available for applicants with disabilities, upon request.