Statistical Programming Director
2 days ago
About the Role:
We are seeking a highly skilled and experienced Director of Statistical Programming to lead our statistical programming team. As a key member of our Biostatistics and Data Management department, you will be responsible for providing strategic leadership and direction to our statistical programming activities.
Key Responsibilities:
- Coordinate outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions.
- Manage contract research organizations (CROs) for multiple projects and ensure timely delivery of high-quality deliverables at reasonable cost.
- Develop and implement global harmonization of programming processes supporting global submission.
- Lead the development of global standard operating procedures for statistical programming practice.
- Oversee compliance with standard procedures and processes.
- Collaborate with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, and regulatory affairs.
Requirements:
- 10+ years of experience in the pharmaceutical industry, preferably in a leadership role.
- Thorough understanding and proficiency of CDISC.
- Advanced knowledge of CDISC requirements for SDTM and ADaM.
- Experience with electronic NDA and/or BLA submission via eCTD.
- Strong project management experience and ability to manage and execute multiple projects and deadlines.
About Daiichi Sankyo, Inc.:
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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