Remote Mern Full-Stack Engineer | Growth & Impact

Placements24; South Africa; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Parexel FSP is seeking a Senior Statistical Programmer (FSP) to join our South Africa team. You will provide technical leadership for programming activities across clinical trials, delivering SDTM/ADaM datasets, tables, and listings, while ensuring QA, regulatory compliance, and timely delivery.

You will collaborate with sponsors and internal teams, lead programming efforts, and apply CDISC standards and trial data workflows in a fast-paced, remote-friendly environment.

Qualifications

• Proficiency in SAS.
• Minimum 3 years clinical/statistical programming experience.
• Experience with upstream data handling e.g. eDC, SDTM.
• Ability to deliver outputs for ADaM, Data Definition Table, e-submission.

Responsibilities

• Lead statistical programming on projects and interact with sponsors.
• Produce/QA SDTM/ADaM datasets, tables, listings, figures.
• Review SAPs and database specs for accuracy and completeness.
• Ensure QC per corporate standards and regulatory requirements.

Skills

SAS proficiency

Project management

Analytical skills

Team collaboration

Regulatory understanding

Tools

MS Office

XML

Pinnacle 21

Job description

Showing 106 Mern Full Stack Engineer Growth Impact jobs in remote

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 programming activities related to the analysis and reporting of clinical study data.

Project Management

• 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.

Statistical Programming for Assigned Projects

• 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