October 16, 2016

Sr. Manager, Stat Programmer BIOMETRICS

Theravance Biopharma US, Inc. - South San Francisco, CA

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Job Description

The Statistical Programming Sr. Manager will be responsible for therapeutic area leadership of a statistical programming team that supports multiple drug development programs.

The position requires a broad, comprehensive and detailed knowledge of statistical programming languages and software, filing support, clinical trial databases, and pharmaceutical drug development process. The incumbent will assist the head of Statistical Programming to develop, recommend, and implement standard procedures, measures of performance, and training programs. Serve as Principle Analyst on programs to organize and allocate resources according to multi-project requirements and deadlines. Provide leadership to the company in the area of technical expertise.

Duties and Responsibilities
The duties and responsibilities include but are not limited to the following:
Act as principle analyst to provide statistical programming service to the therapeutic area
Provide review and supervision of other statistical analysts in a manner that promotes problem solving, career development, and motivation
Develop, revise, and maintain Standard Operating Procedures and Work Instructions
Support the Head of Statistical Programming to achieve the corporate objectives
Stay abreast of current regulatory environment focusing on submission standards
Provide input in the selection of CROs, manage CRO programming activities for complex studies
Lead task forces to develop complex, technical solutions for projects or business needs
Independently bring technical solutions to the Statistical Programming department
Develop and maintain good communications and working relationships with internal/external functions
Ensure that the company business needs and partner organizations are satisfied within agreed-upon timelines with respect to statistical programming activities and the exchange of data sets for clinical studies
Lead the effort of programming process improvement
Assist in validating software products used by the Statistical Programming department