Full-Stack Software Developer (Remote) (Ch1293)

Capitalh; Gauteng; À distance; ZAR 900 000 - 1 200 000; Plein temps

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

Team collaboration

Analytical thinking

Leadership potential

Communication skills

Financial awareness

Outils

SAS

Pinnacle 21

XML

MS Office

Description du poste

Senior Statistical Programmer (FSP) - South Africa

At Parexel FSP people make a difference. We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.

Parexel is currently seeking a Senior Statistical Programmer to join us in South Africa, dedicated to a single sponsor.

Picture Yourself At Parexel: The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data.

What You’ll Do At Parexel:

• Ability to fill Statistical Programming Lead role on projects.
• Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
• Coordinate and lead a statistical programming team to successful completion of a study within given 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 with regard to statistical programming issues.
• Assist project teams in the resolution of problems encountered in the conduct of their 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 quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH‑GCP, and/or other international regulatory requirements.

Here are a few requirements specific to this advertised role:

• 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.
• Have in-depth understanding of clinical data structure (e.g., 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).