Associate Director, Statistical Programming

Emeryville, CA, United States
Oct 14, 2019
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

This position is responsible for implementing and managing the statistical programming activities; leading the development, validation and maintenance of all statistical software (SAS programs) to support statistical analysis in collaboration with biostatisticians, data managers and other project team members from various functional groups for assigned clinical programs. This position will closely work with the Head of Statistical Programming, regulatory representatives, Clinical Operation leadership, clinical scientists and project managers in providing strategic input to the production of study reports and new drug applications. He or she will manage and mentor statistical programmers and leads the effort to develop and maintain all standard operating procedures related to statistical programming and to implement the CDISC standards. This position is responsible for establishing and maintaining the readiness of statistical output including data sets, tables, figures, and listings for registration filing.

  • Manage statistical programming staff and consultants of up to 15 people
  • Performs supervision, goal setting, performance evaluation, and mentoring for direct reports.
  • Work with the Head of Statistical Programming to develop and monitor the department strategic needs and direction and its alignment with company strategies.
  • Contributes to the development of departmental processes and tools for further enhancement in productivity and quality.
  • Oversee the coordination of global statistical programming staff to ensure efficient workflow and use of resources across Santen studies.
  • Applies advanced level programming techniques to support Santen's clinical trials and ad hoc requests, as needed
  • Independently provides technical and project management leadership for programming activities across multiple studies to ensure accurate and on-time delivery
  • Serve as the Statistical Programming representative on cross-functional study teams to provide guidance and input regarding programming activities and timelines
  • Manage CRO programming activities and review deliverables as needed
  • Participation in recruiting processes and logistics to hire individual contributors and helps to train new employees and contractors.
  • Responsible for understanding the impact of industry and company strategies on the programming department and deliverables.
  • Other duties may be assigned as needed

  1. Minimum of 12+ years of SAS programming with 5+ years of pharmaceutical industry experience, with ophthalmic pharmaceutical industry experience preferred.
  2. BS degree or higher and more than 3 years of managerial experience, global or decentralized team management experience preferred
  3. Experience in multiple regulatory agency filings
  4. Knowledge of registration filing requirements for statistical programming.
  5. Advanced SAS programming skills.
  6. Excellent communication skills and collaborative working style is essential.
  7. Knowledge of basic statistics and ability to communicate with statisticians and sometimes non-statisticians to verify and interpret tables, listings, figures.
  8. Excellent organizational and problem-solving skills.
  9. Must work effectively and independently in a team environment.
  10. Experience in reviewing study planning documents, and development of programming specifications.
  11. Knowledge of good Clinical Data Management procedures.
  12. Ability to manage a programming team of up to 15 programmers
  13. Ability to lead statistical programmers to work on multiple projects simultaneously.
  14. Ability to build a rapport and trust with others through leadership and dependability; be self-motivated and able to work well under pressure and shift priorities independently and as a team member; can execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources.
  15. To perform this job successfully an individual must be able to perform each responsibility satisfactorily.
  16. Satisfactory performance depends on the following skill set: organization and planning, problem solving/decision-making, communication, people management, working relationships, and technical expertise.