Full-Stack Software Developer (Remote) (Ch1293)
Senior Statistical Programmer at Parexel (FSP model, dedicated to a single sponsor) in South Africa: leads statistical programming for clinical trials — producing and QC-ing SDTM/ADaM derived datasets, tables, figures and listings with SAS, reviewing analysis plans and database specs, and managing timelines, budgets and submission documentation.
- Compensation
- Not disclosed
- Location
- Gauteng, South Africa
- Work setup
- Not specified
- Seniority
- Lead
- Employment
- Not specified
- Experience
- 3+ years
- Category
- Fullstack
- Posted
Skills
Must have
- Proficiency in SAS
- 3+ years clinical/statistical programming experience in pharmaceutical clinical development
- Handling and processing of upstream data (multiple data forms, workflow, eDC, SDTM)
- Providing outputs meeting downstream requirements (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 databases
- Skills in software tools such as MS Office, XML, Pinnacle 21
- Ability to work in a team environment with clinical team members
- Strong project management skills
- Good business awareness/business development skills including financial awareness
- Ability to fill Statistical Programming Lead role on projects
Full description
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.