Senior Statistical Programmer – FSP

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

📋 Description

• Deliver technical expertise for the execution of clinical trials

• Serve as an internal subject matter expert, offering technical support and specialized advice

• Independently manage programming tasks related to clinical study data analysis and reporting

• Assume the role of Statistical Programming Lead on various projects

• Contribute to and negotiate statistical programming timelines while ensuring compliance

• Organize and lead statistical programming teams to complete studies within established timelines and budget

• Oversee project resources and budgets while identifying any changes in scope

• Manage project initiation activities and create global programs, tracking spreadsheets, and necessary documentation

• Review statistical analysis plans, mock shells, and database setup specifications

• Engage with sponsors and internal stakeholders regarding statistical programming matters

• Support project teams in resolving daily operational challenges

• Utilize efficient programming techniques to generate and validate derived datasets, including SDTM and ADaM/TLF, tables, figures, and data listings

• Create and validate dataset specifications, process-supporting documents, and submission materials

• Ensure the quality control of derived datasets, tables, listings, and figures meets corporate quality standards, SOPs/guidelines, ICH-GCP, and international regulatory requirements

⛳️ Requirements

• Expertise in SAS

• At least 3 years of experience in clinical/statistical programming within pharmaceutical clinical development

• Experience in managing and processing upstream data, encompassing multiple data forms, workflow, eDC, and SDTM

• Proficiency in generating outputs for downstream needs, including ADaM, Data Definition Table, and e-submission

• Strong skills in analytical programming

• Exceptional analytical abilities

• Comprehensive understanding of clinical data structures, including CDISC standards, and relational databases

• Proficient in MS Office, XML, and Pinnacle 21

• Capability to collaborate effectively in a team environment with clinical team members

• Strong project management competencies

• Good business acumen and business development skills, including financial awareness

• A bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences is required

• Proficient written and oral communication skills in English

• Must have authorization to work in South Africa

• Employment visa sponsorship is not available

🏝️ Benefits

• Competitive financial packages

• Opportunities for training and development

• Fully flexible work arrangements

• Option for fully remote work

• Office access available for employees residing nearby

• Healthy work/life balance

• Employee welfare support