When our values align, there's no limit to what we can achieve.
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 goal through the knowledge, expertise, innovation, and commitment of our employees worldwide. 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 clinical trials, acts as an internal subject matter expert in specific areas, provides technical support and expert advice, and works independently on programming activities related to the analysis and reporting of clinical study data.
What You'll Do At Parexel:
- Fill the role of Statistical Programming Lead on projects.
- Input into and negotiate statistical programming timelines, ensuring adherence to schedules.
- Coordinate and lead a statistical programming team to successfully complete studies within timelines and budget.
- Monitor project resourcing, budgets, and scope changes.
- Coordinate project start-up activities, create global programs, tracking spreadsheets, and documentation.
- Review statistical analysis plans and mock-shells.
- Review database setup specifications.
- Interact with sponsors and internal stakeholders regarding programming issues.
- Assist teams in resolving problems encountered during their work.
- Use efficient programming techniques to produce and QC derived datasets (e.g., SDTM, ADaM/TLF), tables, figures, and data listings.
- Produce and QC dataset specifications and submission documentation.
- Ensure quality control in all activities according to standards, SOPs, ICH-GCP, and regulatory requirements.
- Maintain and expand knowledge of regulatory standards and processes.
- Provide training and mentorship to staff and project teams.
- Maintain documentation for studies to ensure traceability and compliance.
- Participate in audits and inspections as required.
- Lead process and quality improvement initiatives.
- Represent Parexel at sponsor meetings.
- Understand regulatory standards like CDISC, 21 CFR Part 11, and electronic submissions.
Requirements:
- Proficiency in SAS programming.
- Minimum of 3 years clinical/statistical programming experience in pharmaceutical development.
- Experience handling upstream data (e.g., multiple data forms, eDC, SDTM).
- Ability to produce outputs meeting downstream requirements (e.g., ADaM, Data Definition Table, e-submission).
- Proficiency in analytical programming.
- Strong analytical skills and understanding of clinical data structures and standards (e.g., CDISC).
- Skills in using software tools like MS Office, XML, Pinnacle 21.
- Ability to work in a team environment.
- Strong project management skills.
- Good business awareness and development skills.
- Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences.
- Fluent in written and oral English.