Candidate will be responsible for leading and directing the statistical programming strategy for safety statistical programming
across all therapeutic areas through own effort and those of their staff. You will provide training and performance management for staff and assist management in resource estimation and resource management. Responsibilities:
Level will be based on education & years of experience. Basic:
- 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 and is bu
- 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 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 Macrodevelopment. 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 years of management experience is required.
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