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Associate Director, Statistical Programming

Employer
Santen, Inc.
Location
Emeryville, CA
Start date
Aug 29, 2019

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Job Details

PRIMARY PURPOSE OF POSITION:

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.

MAJOR DUTIES OF POSITION:
  • 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

KNOWLEDGE AND SKILL REQUIREMENTS:
  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.

Company

Santen is a global pharmaceutical and medical device company focused solely on ophthalmology. We’re committed to serving serious unmet needs by developing innovative solutions that protect vision and, in turn, preserve quality of life for people around the world.

Santen USA, located in Emeryville, CA, is an important part of our ophthalmic research, development, and commercialization efforts worldwide and the home of our regional business teams. By leveraging our deep industry knowledge and a network of external partners, we aim to deliver game-changing therapies and make hope a reality for people facing vision impairment and loss.

Our deep roots start in Japan, Santen’s worldwide headquarters, where the company began in 1890. Since then, Santen has become an established leader in the Asian and European prescription ophthalmology marketplaces and continues to expand across global markets, including the United States. Today, Santen employs more than 4,000 people worldwide and sells specialty ophthalmic products in more than 60 countries.

With a clear focus on vision, we aim to deliver the highest quality products, to act with integrity, to earn the trust of our partners and customers, and to deliver sight-saving innovations to physicians and patients who are waiting for them.
 

 

Company info
Website
Location
6401 Hollis Street
Emeryville, CA 94608
United States

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