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    Senior Analyst/Programmer II - San Diego, United States - WuXi AppTec

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    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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