Associate Director, Statistical Programming
Purpose : Responsible for leading and directing the statistical programming strategy for multiple clinical projects across multiple therapeutic areas through own effort and those of their staff. Provide training and performance management for staff. Assist management in resource estimation and resource management.
Key Responsibilities Includes :
Key Responsibilities Includes :
- 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.
- 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 Interation: 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.
- 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.
- MS in Statistics, Computer Science or a related field with 12+ years of relevant experience. OR BS in Statistics, Computer Science or are related field with 14+ years of relevant experience.
- High degree of technical competence and communication ability, both oral and written. 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. Thorough understanding of ICH Guidelines and
relevant regulatory requirements. A minimum of 5 yrs management experience required.