Covance

  • Manager of Statistical Programming

    Job Location(s) US-NC-Research Triangle Park | US-NJ-Princeton | US-PA-King of Prussia | US-PA-Philadelphia | US-TX-Austin | CA-ON-Toronto | CA-ON-Mississuaga | US-IL-Chicago | US-MO-Kansas City | US-CA-San Francisco | US-CA-Oakland | ...
    Job Number
    2019-27066
    Job Category
    Biostatistics/Programming
    Position Type
    Full-Time
  • Job Overview

    Manager of Statistical Programming

    permanent, salaried

    Remote from anywhere in the U.S. or Canada

     

    Responsibilities

    Supervision of less-experienced statistical programmers within project activities.
    ¨ Statistical Programming lead for large global or other major programs.
    ¨ Carry out line management responsibilities for assigned staff, including Performance
    Management and Development activities, disciplinary procedures and administrative activities.
    ¨ Work with Training specialists and other disciplines to ensure all members of the department
    receive training required to fulfill current role or to develop further.
    ¨ Encourage an open and communicative two-way interaction with line reports.
    ¨ Training and development of less-experienced staff within the department.
    ¨ Provide training on statistical programming related topics.
    ¨ Contribute to review and amendment of departmental processes and supporting documentation.
    ¨ Facilitate the flow of information, comment and feedback between senior management and all
    levels of staff.
    ¨ Assume responsibilities for Lead Statistical Programmer or other statistical programming
    responsibilities, e.g., DMC/IA unblinded programmer. Tasks include, but are not limited to
    protocol review, CRF input, Statistical Analysis Plan review, responsibility for Statistical
    Programming deliverables, analysis, reports and SAS programming.
    ¨ Provide statistical programming input into other disciplines' activities and participate in
    interdepartmental processes.
    ¨ Determine documentation requirements for statistical programming aspects of projects. Give
    guidance to support business and regulatory requirements including definition of appropriate
    documentation, storage/communication media, and retention/return of documents at study
    close-out.
    ¨ Initiate and participate in the ongoing review of the processes used by the Statistical
    Programming group to ensure processes are continually improved.
    ¨ Ensure mechanisms in place to maintain flow of appropriate information between disciplines
    on project team encouraging proactive communication.
    ¨ Project management activities for identified projects including financial, resource planning and
    utilization, timelines and milestone management.
    ¨ Contact with client for technical issues.
    ¨ Maintain a positive approach, building a motivating and professional team environment.
    ¨ Provide input and review of new business proposals, including time and cost estimates and
    associated documentation; participate in associated client development activities.
    ¨ Represent the statistical programming during audits, particularly those related to new client
    opportunities.
    ¨ Perform ongoing financial review of projects assigned to, ensure that all issues are highlighted
    and resolved as quickly as possible and all non-contract tasks are identified, tracked and
    included in change order forms
    ¨ Ensure all Statistical Programming activities are carried out in accordance with Covance or
    project specific processes
    ¨ Carry out all activities according to appropriate Covance SOPs, working within the framework
    of the Quality Management System and to GCP.
    ¨ Perform other duties as requested by management.

     

    Required Experience

    8 years experience in provision of programming support for clinical trial management and
    reporting, or equivalent experience
    ¨ Supervisory skills gained from lead program oversight of large scale projects utilizing project
    management skills and team leadership as demonstrated by the ability to organize and motivate
    project teams
    ¨ Extensive experience and proven skills in the use of SAS within a Statistical Programming
    environment
    ¨ Knowledge of all aspects of clinical trials form initial study set-up to study completion
    ¨ Complete knowledge and understanding of the processes and procedures used within a
    Statistical Programming environment and the ability to communicate to programmers and
    nonprogrammers alike
    ¨ Full understanding of the job roles in programming, to be able to identify training and
    development needs, opportunities for optimizing staff utilization and employing the most
    efficient practices
    ¨ An excellent understanding of the roles and responsibilities of all related disciplines, e.g.
    Biostatistics and Clinical Data Management
    ¨ Ability to apply extensive technical expertise and full knowledge of other related disciplines to
    provide consultancy and advice on programming and wider related issues to other departments
    and disciplines
    ¨ Excellent problem solving skills, a proactive approach, anticipating issues and working to
    ensure they are avoided or resolved as quickly as possible
    ¨ A willingness to make decisions, seeking advice from senior Statistical Programming staff to
    confirm decisions when necessary
    ¨ Excellent organizational skills and the ability to delegate and prioritize work
    ¨ Self motivation and the ability to work independently, excellent time management skills and
    the ability to work to tight deadlines whilst maintaining the highest standards of work
    ¨ Good interpersonal skills and the ability to communicate appropriately with all levels of staff
    throughout the global organization and confidently with other disciplines and external clients
    ¨ Ability promote a good team working environment, providing the client with a high quality
    service whilst recognizing our business needs
    ¨ A proactive approach to developing and maintaining effective working relationships with staff
    in other disciplines, often in other locations and in working to achieve consistent processes and
    standards across them
    ¨ A co-operative and team orientated approach.
    ¨ Good interview skills to ensure successful recruitment of high caliber candidates
    ¨ Good general business awareness and an understanding of the business needs of a CRO

    Education/Qualifications

    ¨ BSc in a computing, life science, mathematical or statistical subject.
    ¨ A high computing content is considered to be beneficial; however proven computing skills are
    most important
    ¨ Alternative academic qualifications or experience are assessed to ensure equivalent background

    Experience

    ¨ 8 years experience in provision of programming support for clinical trial management and
    reporting, or equivalent experience
    ¨ Supervisory skills gained from lead program oversight of large scale projects utilizing project
    management skills and team leadership as demonstrated by the ability to organize and motivate
    project teams
    ¨ Extensive experience and proven skills in the use of SAS within a Statistical Programming
    environment
    ¨ Knowledge of all aspects of clinical trials form initial study set-up to study completion
    ¨ Complete knowledge and understanding of the processes and procedures used within a
    Statistical Programming environment and the ability to communicate to programmers and
    nonprogrammers alike
    ¨ Full understanding of the job roles in programming, to be able to identify training and
    development needs, opportunities for optimizing staff utilization and employing the most
    efficient practices
    ¨ An excellent understanding of the roles and responsibilities of all related disciplines, e.g.
    Biostatistics and Clinical Data Management
    ¨ Ability to apply extensive technical expertise and full knowledge of other related disciplines to
    provide consultancy and advice on programming and wider related issues to other departments
    and disciplines
    ¨ Excellent problem solving skills, a proactive approach, anticipating issues and working to
    ensure they are avoided or resolved as quickly as possible
    ¨ A willingness to make decisions, seeking advice from senior Statistical Programming staff to
    confirm decisions when necessary
    ¨ Excellent organizational skills and the ability to delegate and prioritize work
    ¨ Self motivation and the ability to work independently, excellent time management skills and
    the ability to work to tight deadlines whilst maintaining the highest standards of work
    ¨ Good interpersonal skills and the ability to communicate appropriately with all levels of staff
    throughout the global organization and confidently with other disciplines and external clients
    ¨ Ability promote a good team working environment, providing the client with a high quality
    service whilst recognizing our business needs
    ¨ A proactive approach to developing and maintaining effective working relationships with staff
    in other disciplines, often in other locations and in working to achieve consistent processes and
    standards across them
    ¨ A co-operative and team orientated approach.
    ¨ Good interview skills to ensure successful recruitment of high caliber candidates
    ¨ Good general business awareness and an understanding of the business needs of a CRO

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