Manager of Statistical Programming
vor 1 Woche
We are a leading pharmaceutical company, SEC Life Sciences, dedicated to improving lives through innovative healthcare solutions. Our mission is to deliver new standards of care that enhance the quality of life globally.
Cardiovascular Health:
Oncology: We strive to become a global pharma innovator by creating novel therapies for cancer patients.
Your Role as Manager Statistical Programming:
- Oversee the end-to-end delivery of statistical programming services for assigned studies.
- Collaborate with Contract Research Organizations (CROs) and other vendors to ensure high-quality deliverables are on time and within budget.
- Review Statistical Analysis Plans (SAPs) and Transformed Flow Logic (TFL) shells from a programming perspective.
- Develop and validate SAS programs to create Standard Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets and TFLs.
- Ensure timely and accurate completion of statistical programming deliverables.
Regulatory and Compliance:
- Contribute to documents submitted to regulatory or pricing authorities.
- Maintain inspection readiness and prepare for potential audits linked to assigned studies.
Requirements for the Manager Statistical Programming Role:
- Bachelor's degree in Statistics, Computer Science, Mathematics, or a related field.
- Relevant experience in statistical programming within the pharmaceutical industry.
Key Skills:
- Proficiency in SAS programming.
- Familiarity with XML/PDFs, ARM, aCRFs, and Reviewers Guides.
- Ability to manage multiple projects and collaborate with various stakeholders.
Regulatory Knowledge:
- Understanding of regulatory requirements and guidelines for statistical programming.
- Experience with inspection readiness and audit preparation.
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