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Principal Statistical Programmer (Sheffield, UXB or Decentralized, UK)

Employer
Parexel
Location
Sheffield, United Kingdom
Salary
Competitive
Start date
14 Feb 2019
Closing date
16 Mar 2019

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Discipline
Data Management / Statistics, Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

The Principal Statistical Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Principal Statistical Programmer can fill the Primary Statistical Programmer role on projects and liaise with sponsors, Data Operations Leads, and other functional areas as required. Furthermore, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Job Purpose:

Key Accountabilities:
  • Ability to fill Statistical Programming Lead role on projects
  • Input into and negotiate statistical programming timelines.
  • Ensure that timelines are adhered to.
  • Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
  • Monitor project resourcing, project budgets, and identify changes in scope.
  • Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
  • Review statistical analysis plans and mock-shells.
  • Review database set-up specifications.
  • Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
  • Interact with sponsors and internal stakeholders with regard to statistical programming issues.
  • Assist project teams in the resolution of problems encountered in the conduct of their daily work.
  • Deliver best value and high quality service.
  • Check own work in an ongoing way to ensure first-time quality.
  • Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.
  • Produce/QC dataset specifications and other process supporting documents and submission documentation.
  • Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards,
  • SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.
  • Maintain and expand local and international regulatory knowledge within the clinical industry.
  • Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other PAREXEL functional areas.
  • Provide relevant training and mentorship to staff and project teams.
  • Lead knowledge sharing forums and proactively support the development of the wider department.
  • Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
  • Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
  • Proactively participate in and/or lead process/quality improvement initiatives. Qualifications Skills:
  • Excellent analytical skills.
  • Advanced knowledge of SAS programming techniques.
  • Extensive knowledge and understanding of the programming and reporting process.
  • Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
  • Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated.
  • Ability to learn new systems and function in an evolving technical environment.
  • Strong project management skills.
  • Strong organizational skills, ability to manage competing priorities, and flexibility to change.
  • Attention to detail.
  • Ability to successfully lead and mentor a global team.
  • Work effectively in a quality-focused environment.
  • Excellent time management in order to meet daily metrics or team objectives.
  • Show commitment to and perform consistently high quality work.
  • Strong business/operational skills that include customer focus, commitment to quality management, and problem solving.
  • Demonstrate commitment to refine quality processes.
  • Good presentation skills.
  • Ability to negotiate and influence in order to achieve results.
  • Good business awareness/business development skills (including financial awareness).
  • Client-focused approach to work.
  • Good negotiation skills.

    Knowledge and Experience:
  • Competent in written and oral English.
  • Excellent communication skills.
  • Proven record of successfully leading teams in a statistical programming environment.

    Education:
  • Educated to degree level in a relevant discipline and/or equivalent work experience. Skills:
  • Excellent analytical skills.
  • Advanced knowledge of SAS programming techniques.
  • Extensive knowledge and understanding of the programming and reporting process.
  • Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.
  • Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated.
  • Ability to learn new systems and function in an evolving technical environment.
  • Strong project management skills.
  • Strong organizational skills, ability to manage competing priorities, and flexibility to change.
  • Attention to detail.
  • Ability to successfully lead and mentor a global team.
  • Work effectively in a quality-focused environment.
  • Excellent time management in order to meet daily metrics or team objectives.
  • Show commitment to and perform consistently high quality work.
  • Strong business/operational skills that include customer focus, commitment to quality management, and problem solving.
  • Demonstrate commitment to refine quality processes.
  • Good presentation skills.
  • Ability to negotiate and influence in order to achieve results.
  • Good business awareness/business development skills (including financial awareness).
  • Client-focused approach to work.
  • Good negotiation skills.

    Knowledge and Experience:
  • Competent in written and oral English.
  • Excellent communication skills.
  • Proven record of successfully leading teams in a statistical programming environment.

    Education:
  • Educated to degree level in a relevant discipline and/or equivalent work experience.

    • Company

    parexel

    When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

    How to describe Parexel’s culture in one word: 

    Henry

     

     

    Working With Heart™ - Christina's perspective:

    Working With Heart™ - Christina's perspective:

     

    Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

    Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
     Uxbridge
    Middx
    UB8 1LZ
    United Kingdom
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