Director, Statistical Programming - Immunology (Hybrid)

Job Description

The Director, Statistical Programming is a key leadership role responsible for overseeing a team of both new and experienced programmers. They will be leading and managing the statistical programming team to ensure efficient and high-quality deliverables. This role will have a strong focus on multiple indications within a specific therapeutic area, ensuring that all programming activities align with the overall clinical development strategy. The Director will collaborate closely with cross-functional teams to provide strategic input and support decision-making processes. They will also be responsible for establishing and maintaining standard operating procedures to ensure compliance with regulatory requirements and industry best practices.

Responsibilities:

• SAS Programming: Demonstrated extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Able to critically review programming techniques and strategy. Recognizes limitations in programming strategy and corrects flaws proactively.
• Standards: Monitors and interprets industry/regulatory trends and regulatory guidance. Sets both short and long term vision for programming standards. Ensures programming standards work seamless with related function’s standards.
• DATABASE ACTIVITIES: Case report forms and database definitions: Provides strategic guidance on the development of CRFs and database designs. Provides strategic guidance on global standards related to CRF designs and database designs.
• Derivation Programming, Submission Data Sets and Programs: Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications. Monitors and interprets industry/regulatory trends and regulatory guidance. Sets both short and long term vision for programming standards
• Client Interaction: Works collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas. Builds relationships with external partners and service organizations. Demonstrates an understanding of drug development principles. Anticipates potential problems within and across projects and develops appropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels. Provides strategic guidance
• Communication: Effectively and persuasively presents statistical programming concepts, assessment of risks and impacts and logical arguments to other statistical programmers, statisticians, scientists and non-scientists. Effectively presents information through planning and execution of meetings and presentations.
• Training and Mentoring: Provides coaching and mentoring to first line managers when needed. Provides strong professional and technical leadership to maintain highly motivated staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures consistency of training opportunities across the organization. Ensures that self and staff are compliant with training requirements.
• Resource Management: Manages statistical programming staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects. Responsible for assisting the Global Director of Statistical Programming in preparing global resource planning.
• Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.
• Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views.

Qualifications

Minimum Qualifications:

• MS in Statistics, Computer Science or a related field with 12+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 14+ years of relevant experience.
• Highly competent in SAS programming and Macro development.
• Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience.
• A minimum of 5 yrs management experience required.
• Previous experience leading direct reports

Preferred Qualifications:

• Immunology Experience
• Experience utilizing AI in statistical programming activities

Other Required Skills:

• High degree of technical competence and communication ability, both oral and written.
• Thorough understanding of ICH Guidelines and relevant regulatory requirements.

Additional Information

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