Senior Statistical Programmer – Clinical Trials Lead

Capitalh; Gauteng; Remote; ZAR 900,000 - 1,200,000; Full time

Job summary

Parexel is seeking a Senior Statistical Programmer in South Africa to provide technical expertise for clinical trials and to act as an internal SME in statistical programming. The role involves leading programming activities, ensuring timelines, budgets, and quality standards are met.

The position requires SAS proficiency, 3+ years of pharmaceutical programming experience, strong data handling skills (SDTM/ADaM), and the ability to work collaboratively with sponsors and cross-functional teams in

Qualifications

• Proficiency in SAS.
• Proven clinical / statistical programming experience within pharmaceutical clinical development (3 years minimum).
• Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
• Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
• Demonstrated proficiency in analytical programming.
• Excellent analytical skills.
• In-depth understanding of clinical data structure (CDISC standards) and relational database.
• Demonstrated skills in using software tools and applications, e.g., MS Office, XML, Pinnacle 21.
• Demonstrated ability to work in a team environment with clinical team members.
• Strong project management skills.
• Good business awareness/business development skills (including financial awareness).

Responsibilities

• Fill Statistical Programming Lead role on projects.
• Input into and negotiate statistical programming timelines; ensure timelines are adhered to.
• Coordinate and lead a statistical programming team to successful completion of a study within timelines and budget.
• Monitor project resourcing, project budgets, and identify changes in scope.
• Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
• Review statistical analysis plans and mock-shells.
• Review database set-up specifications.
• Interact with sponsors and internal stakeholders regarding statistical programming issues.
• Assist project teams in resolving problems encountered in daily work.
• Use efficient programming techniques to produce/QC derived datasets (e.g., SDTM, ADaM/TLF), tables, figures, and data listings.
• Produce/QC dataset specifications and other process supporting documents and submission documentation.
• Ensure QC is performed on all process and technical activities related to derived datasets, tables, data listings, and figures per standards.

Skills

Team collaboration

Analytical thinking

Leadership potential

Communication skills

Financial awareness

Tools

SAS

Pinnacle 21

XML

MS Office

Job description

Parexel is seeking a Senior Statistical Programmer in South Africa to provide technical expertise for clinical trials and to act as an internal SME in statistical programming. The role involves leading programming activities, ensuring timelines, budgets, and quality standards are met.

The position requires SAS proficiency, 3+ years of pharmaceutical programming experience, strong data handling skills (SDTM/ADaM), and the ability to work collaboratively with sponsors and cross-functional teams in