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Senior Manager, Statistical Programming Infrastructure and Systems - United States  

Company managed [?] Still accepting applications

Posted on : 13 June 2017

Project Description

 Description:
The Statistical Programming Group within the Department of Bio statistics is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines.



Essential Functions
  • Responsible for development and maintenance of company's new SAS Server environment.
  • Responsible for development and validation of CDISC automation tools
  • Lead development of software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
  • Develop software validation procedures and test plans, as necessary.
  • Create SOPs and Work Instructions for statistical programming development, validation and maintenance processes.
  • Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
  • Possibly oversee work of internal contract programmers and external vendors.
  • Assist in development of standards for time and resource estimates for project planning.
  • Assist in development of training and onboarding statistical programmers.



Minimum Requirements
  • Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master’s Degree preferred
  • Minimum of 10 years of experience in developing software for clinical trials using the SAS system.
  • Highly skilled in programming with SAS and developing macros. Knowledge of additional programming languages a plus.
  • Good knowledge of statistics and drug development process
  • Experience as a lead programmer for complex technical projects
  • Experience overseeing the work of internal contractors and external vendors (CROs) is a plus
  • Excellent knowledge of CDISC standards, including SDTM and ADaM models
  • Solid verbal and written communication skills
 


Equal Opportunity:
Our company  is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.