Job Summary

This position serves as the Global Head of the Statistical Programming Group. The incumbent will be responsible for defining the vision and mission of the programming group; be accountable for the quality, timeline, and strategy of all statistical programming activities and deliverables related to global R&D projects and regulatory submissions; provide leadership and manage the programming group for organization build, talent development, resource planning, and people development; lead the development, improvement, implementation, and maintenance of global programming processes, standards, programing innovation technology, and programming infrastructure; be responsible for the compliance of GxP, SOP/SOI, and other regulations and company policies in programming practice. Oversee and partner with IT to obtain and maintain software used by GBDM (e.g. SAS, R, Python). Support the advancement of new technologies (AI/ML) and new systems (e.g. Clinical Data Repository). Prepare and support inspections related to Statistical Programming activities and deliverables

Job Description

Responsibilities

Statistical Programming Management:

• Define the vision and mission of the group; manage statistical programming resources to support project needs; be accountable for the quality of the statistical programming deliverables; be responsible for recruiting, retaining, developing, and managing employees; be responsible for talent development including providing guidance for career growth and providing development opportunities for the direct reports. Global Biostatistics & Data Management (BDM) Strategy to Improve Drug Development: Leads the implementation of the BDM vision and strategy, and identifies technology and infrastructure needs and leads the development and improvement of needed technology and infrastructure for the function to improve harmonization and efficiency which leads to cost savings and productivity. Initiate and lead the development or enhancement of global programming processes and standards for statistical programming practice. The leadership of strategic initiative and cross-functional collaboration: Provide leadership for global strategic and process improvement initiatives within Biostatistics & Data Management. Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, QCP, and regulatory affairs, etc. Compliance: Be sponsible for the compliance of GxP, SOP/SOI, and other regulations and company policies in programming practice
• People & Organization Leadership: Lead, develop, and inspire a global statistical programmers and leader; Build a strong leadership bench and talent pipeline through succession planning, capability development, and performance management; Foster a culture of collaboration, accountability, inclusion, and continuous learning.  Act as a Statistical Programming Technical expert to the department and the global BDM department.
• Global Biostatistics & Data Management (BDM) Strategy to Improve Drug Development: Leads the implementation of the BDM vision and strategy, and identifies technology and infrastructure needs and leads the development and improvement of needed technology and infrastructure for the function to improve harmonization and efficiency which leads to cost savings and productivity. Initiate and lead the development or enhancement of global programming processes and standards for statistical programming practice.
• The leadership of strategic initiative and cross-functional collaboration: Provide leadership for global strategic and process improvement initiatives within Biostatistics & Data Management. Ensure close collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, QCP, and regulatory affairs, etc. Represent Statistical Programming in governance forums and senior leadership discussions.  Serve as a trusted partner to global stakeholders, including IT, Biostatistics, Data Management and the wider Data Sciences Community at the company.

Compliance:

• Be responsible for the compliance of GxP, SOP/SOI, and other regulations and company policies in programming practice

Qualifications

Education Qualifications:

• Bachelor's Degree Mathematics, Statistics or Computer Science required
• Master's Degree Mathematics, Statistics or Computer Science preferred

Experience Qualifications:

• 12 or More Years with MS or 15 + with BS years minimum experience in pharmaceutical industry. Extensive experience in oncology drug development including NDA and/or BLA submission, extensive hands on experience and knowledge in statistical programming and related processes/standareds, extensive project management skills and experience, people management experience are required.
• 6 or More Years Experience in oncology drug development preferred
• 5 or More Years of project management and people management experience; sufficient related skills are required required 
• Excellent Verbal and Written Communication skills
• Functional and organizational skills and knowledge
• Strategic thinking and business vision
• Interpersonal skills
• Deep technical expertise and experience in R, Python and SAS
• Proven track record of overseeing and knowledge of statistical programming systems
• Experience leading technical/systems initiatives for global BDM
• Experience leading and managing a large global department
• Proven track record partnering with Data Management and Biostatistics globally
• Flexible thinking; able to pivot quickly in a highly dynamic, fast paced environment.