Statistical Programming Associate Director- CVRM

at  AstraZeneca

TYPICAL ACCOUNTABILITIES:

You are responsible for leading and advising the full scope of project delivery and/or lead a technical project within the Therapeutic Area (T/Drug Project/Study/Function.

• Leading implementation of statistical programming aspects of the protocol or clinical development program
• Responsible for the high quality of all project results, holding partners and providers accountable for the quality of their work or technical subject matter expert for aspect(s) of the TA, Project, or function
• Leading or contributing to cross-functional administrative or process improvement initiative(s)
• Driving the development of standard processes to improve quality, efficiency and/or effectiveness within the function
• Driving standards development and implementation
• Providing technical expertise to the team
• Providing tactical inputs and/or driving ideas and improvements
• Contributing to the function by supporting recruiting and/or providing training and mentorship
• Finding opportunities to improve methodology and provides practical solutions for problems
• Handling activities of our external partners (i.e. Contract Research Organisations)
• Influencing partners by providing subject matter expertise on programming related items
• Ensuring compliance to standards and automation usage
• Employing all project management practices in running drug or technical projects
• Providing input to capacity management for all projects in scope
• Maintaining expertise of the latest industry and regulatory requirements to stay current

EDUCATION, QUALIFICATIONS, SKILLS, AND EXPERIENCE:

• Degree in Mathematics (i.e., Applied Math, Engineering, etc), Statistics, Computer Science, Life Science, or equivalent
• At least 7 years of relevant experience
• Excellent programming skills in SAS (or R) and SAS macros
• Thorough knowledge of the clinical development process
• knowledgeable of industry standards (CDISC) and ability to implement them
• Ability to apply programming expertise to problem solving and troubleshooting for teams
• Current knowledge of technical and regulatory requirements relevant for the role
• Ability to proactively handle concurrent activities within a project
• Proficient ability to influence relevant partners on programming related items
• Ability to handle risk in complicated or novel situations
• Project Mindset

DESIRABLE SKILLS/EXPERIENCE:

• Broad experience across multiple therapeutic areas and across all phases of clinical trials
• Experience in regulatory submissions and interactions

INTRODUCTION TO THE ROLE:

This role is a delivery focused technical leadership role for programming and overseeing deliverables with quality and timeliness, following established standards and processes. This leadership role requires profound programming experience and excellent industry knowledge to independently lead implementation of programming activities and guide other programmers. You will provide subject matter expertise within the Programming discipline and act as a specialist within cross-functional teams to deliver continuous improvement.

You are responsible for leading and advising the full scope of project delivery and/or lead a technical project within the Therapeutic Area (T/Drug Project/Study/Function.

• Leading implementation of statistical programming aspects of the protocol or clinical development program
• Responsible for the high quality of all project results, holding partners and providers accountable for the quality of their work or technical subject matter expert for aspect(s) of the TA, Project, or function
• Leading or contributing to cross-functional administrative or process improvement initiative(s)
• Driving the development of standard processes to improve quality, efficiency and/or effectiveness within the function
• Driving standards development and implementation
• Providing technical expertise to the team
• Providing tactical inputs and/or driving ideas and improvements
• Contributing to the function by supporting recruiting and/or providing training and mentorship
• Finding opportunities to improve methodology and provides practical solutions for problems
• Handling activities of our external partners (i.e. Contract Research Organisations)
• Influencing partners by providing subject matter expertise on programming related items
• Ensuring compliance to standards and automation usage
• Employing all project management practices in running drug or technical projects
• Providing input to capacity management for all projects in scope
• Maintaining expertise of the latest industry and regulatory requirements to stay curren