Senior Statistical Programmer – FSP

• Provide technical expertise for the conduct of clinical trials
• Act as an internal subject matter expert, providing technical support and expert advice
• Work independently on programming activities related to clinical study data analysis and reporting
• Fill the Statistical Programming Lead role on projects
• Input into and negotiate statistical programming timelines and ensure adherence
• Coordinate and lead statistical programming teams to complete studies within timelines and budget
• Monitor project resourcing and budgets and identify scope changes
• Coordinate project start-up activities and create global programs, tracking spreadsheets, and required documentation
• Review statistical analysis plans, mock shells, and database set-up specifications
• Interact with sponsors and internal stakeholders on statistical programming issues
• Assist project teams in resolving daily work problems
• Use efficient programming techniques to produce and QC derived datasets, including SDTM and ADaM/TLF, tables, figures, and data listings
• Produce and QC dataset specifications, process-supporting documents, and submission documentation
• Ensure QC of derived datasets, tables, listings, and figures complies with corporate quality standards, SOPs/guidelines, ICH-GCP, and international regulatory requirements

• Proficiency in SAS
• Minimum 3 years of clinical/statistical programming experience within pharmaceutical clinical development
• Experience handling and processing upstream data, including multiple data forms, workflow, eDC, and SDTM
• Experience producing outputs for downstream requirements, including ADaM, Data Definition Table, and e-submission
• Proficiency in analytical programming
• Excellent analytical skills
• In-depth understanding of clinical data structures, including CDISC standards, and relational databases
• Proficiency with MS Office, XML, and Pinnacle 21
• Ability to work in a team environment with clinical team members
• Strong project management skills
• Good business awareness and business development skills, including financial awareness
• Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required
• Competent written and oral English
• Must be authorized to work in South Africa
• Employment visa sponsorship is unavailable

• Competitive financial packages
• Training and development
• Fully flexible work arrangement
• Fully home based work option
• Office access for employees who live close to the office
• Healthy work/life balance
• Employee welfare support