Job Summary
The Associate Director/Director plays a crucial role in providing both technical and operational guidance for statistical programming within clinical trials and development initiatives. This position is pivotal in ensuring that all programming outputs, which encompass datasets and submission documentation, meet high standards of quality, accuracy, and regulatory compliance.
Responsibilities
- Lead the statistical programming efforts for clinical studies and developmental projects.
- Guarantee the quality and regulatory adherence of all programming deliverables.
- Manage the preparation of datasets and the documentation required for submissions.
Qualifications
- A minimum of 10 years’ experience in statistical programming within the pharmaceutical or biotechnology sectors, including expertise in BLA/NDA/MAA submissions.
- A bachelor’s or advanced degree in a quantitative field is essential.
- Proficiency in SAS programming is required, alongside extensive knowledge of CDISC standards.
