Director Statistical Programming
Daiichi Sankyo US
United States
See who Daiichi Sankyo US has hired for this role
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryProvide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global submission. Responsibilities
- Statistical Programming Management: Coordinates outsourced statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth knowledge of regulatory authority’s requirements. Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide career growth and provide development opportunity for statistical programmers. Manages contract statistical programming staff to ensure proper resource allocation for achieving successful project deliverables. Provides oversight of all statistical programming activities performed by contractors in different oncology trials as well as submission-related activities, e.g., integrated summary of safety (ISS) and integrated summary of efficacy (ISE).
- Direct Project Support: Providing direct support to key studies in order to ensure sufficient planning of statistical deliverables from vendors as well as work by in-house statistical programmers.
- CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of budget, resources, and timelines for contract research organizations (CROs) for multiple projects and ensures timely delivery of high quality deliverables at reasonable cost. Identify/develop tools for efficient vendor management.
- Global Health Authority Interaction / Negotiation: Reviews documents and responses submitted to health authorities globally with respect to data standards, compliance, etc. May represents the function at health authority meetings. Reviews and provides input to TLF shells for submission documents (e.g., ISE and ISS). Develops the process for ensuring that analysis data sets and outputs are compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer’s guides, etc.
- Global Biostatistics
- Leadership of Strategic Initiative and Cross-Functional Collaboration: Provide leadership for strategic and process improvement initiatives within Biostatistics
- Bachelor's Degree an accredited institution in a science or in a technical field preferred
- Master's Degree preferred Experience Qualifications
- 10 or More Years experience (Bachelor 12 or More Years) in pharmaceutical industry preferred
- Thorough understanding and proficiency of CDISC. preferred
- Advanced knowledge of CDISC requirements for SDTM and ADaM. preferred
- Worked and played major role in electronic NDA and/or BLA submission via eCTD preferred
- Working knowledge in statistics as measured by ability to interpret SAPs/shells to generate ADaM and TLFs. preferred
- Strong project management experience and ability to manage and execute multiple projects and deadlines. preferred
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Seniority level
Not Applicable -
Employment type
Full-time -
Job function
Marketing, Public Relations, and Writing/Editing -
Industries
Biotechnology Research, Hospitals and Health Care, and Pharmaceutical Manufacturing
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