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Senior Analyst/Programmer II - San Diego, United States - WuXi AppTec
Description
Overview
The primary responsibilities of this position will be to lead database or statistical programming activities and provideend to end programming support in planning, specifying, designing, developing, and implementing solutions for theclinical trials in accordance with applicable processes. Provide extensive technical expertise as part of the Databaseand Statistical Programming (DSP) team to develop, test, maintain, validate, and document programs to meet businessneeds. Provide support to the development of project-related solutions to the full scope of database and statisticalprogramming tasks.
Responsibilities
Leads all the programming activities, including planning, organizing, delegating, coordinating, and managing programming activities, from start to finish by overseeing all development, validation, and production of programs for a set of studies or multiple clients
Provides technical solutions to a wider range of problems with higher level of complexity
Independently determines and develops approach to solutions
Adapts to changing circumstances, policies, work assignments, and/or team members
Creates and maintains complete and up-to-date study documentations in compliance with Pharmapace and regulatory standards
Tracks projects against goals and submits status reports to project management
Recommends technical and process solutions that can be used or developed to increase efficiency of project work
May maintain or develop departmental procedures and standards
Contributes to the development of department-level standards, tools and templates
Contributes to user aspects of technical infrastructure or business process initiatives with a focus on statistical programming, data process and analysis reporting procedures
Negotiates effectively within project teams and working groups for reasonable timelines and scope, also negotiates alternative timelines based on resourcing / priority constraints
Manages projects independently
Mentors junior analysts/programmers
May supervise junior analysts/programmers
Qualifications
Education
Bachelors or above degree in statistics/biostatistics, computer sciences, or related fields
Experience
Minimum 8 years of experience in the pharmaceutical/biotech industry for Bachelors and 6 years for Masters
Experience in leading the programming activities for submissions
Skills
Excellent skills in SAS programming or clinical studies
Excellent clinical trial knowledge is preferred
Working knowledge of other software such as S-plus and WinNonlin is preferred
Excellent knowledge in industry standards, such as the ICH guidelines, CDISC data standards, 21 CFR Part 11, and FDA guidelines, is required
Excellent organizational skills, time management, and ability to coordinate workload and meet established timelines
Excellent communication and interpersonal skills to effectively interface with other
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Job Locations US-CA-San Diego
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