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Principal Statistical Programmer (FSO) South Africa

South Africa, Remote Date posted 11/22/2022 Job ID R0000006069

As a member of Parexel’s Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and therapeutic areas, or choose to focus your career on working with a specific sponsor and gaining in depth knowledge of a specific therapeutic area and compound.

You will become a part of a team with an inherent breadth of knowledge and expertise in small, single center Investigator studies to multi-site, multi-national trials in Phases I to IV of clinical development, as well as observational studies. From initial planning meetings at the study design stage through to implementation and execution, our team of skilled statistical programmers will employ industry-accepted statistical tools and techniques, as well as innovative consulting, to provide the quality and efficiency of projects.

Parexel develops and delivers cost effective, high-quality training programs for those employees that are directly involved with sponsor functional partnerships to ensure that our statistical programmers can quickly step in to make significant contributions to the success of a study. In addition, you will receive the opportunity to shape your development through quarterly conversations with your manager. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Team player
  • Tech-Savvy
  • Communicator
  • Proactive
  • Detail-oriented
  • Analytical
  • "I have learned a great deal and developed my expertise. The management team here is open and honest and it is refreshing to be treated with a high degree of trust and flexibility. I have been fortunate to work on a wide variety of projects and partnerships and the work is always interesting."

    Richard – Principal Statistical Programmer

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Development

    Opportunity to learn and grow through a performance and development goal-setting program.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Variety

    Opportunity to work on a wide range of therapeutic areas and medical devices.

Responsibilities

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 Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Essential Skills / Knowledge & Experience Required:

  • Excellent analytical skills.

  • Proven record of successfully leading teams in a statistical programming environment.

  • 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.

  • Excellent communication skills.

  • Competent in written and oral English.


Education:

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

Key Accountabilities:

Project Management:

  • 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.

Statistical Programming for Assigned Projects:

  • 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.

Training:

  • 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.

General:

  • 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.

  • Provide consultancy to internal and external sponsors with regard to statistical programming tasks.

  • Represent PAREXEL at sponsor marketing and technical meetings.

  • Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity.

  • Represent Statistical Programming on cross-functional technical initiatives.

  • Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).


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