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Principal Statistical Programmer

USA - Any Region - Home Based Date posted 05/05/2021 Job ID 60543BR

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.

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

Be part of our empowered Parexel Statistical Programming team today!


Principal Statistical Programmer (with SDTM experience) - to contribute to meaningful advances that benefit patients in need.

Location - Home based US


As a Principal or Senior Programmer you will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. Parexel will provide you with the perfect opportunity to expand on your experiences and develop new skills in a stimulating work environment


KEY RESPONSIBILITIES include (not an exhaustive list of duties):
  • 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
  • Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards
  • Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
  • Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and sponsors
  • Provide leadership, project specific training, stakeholder management, external sponsor support,resource management, and project management for the required programming tasks supporting clinical trial activities

Qualifications

Skills
  • Proficiency in SAS
  • Knowledge of the programming and reporting process
  • Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
  • Strong leadership skills
  • Ability to successfully work together with a (“virtual”) team (including international teams as required) as well as independently
  • Excellent analytical skills
  • Effective time management in order to meet daily metrics or team objectives
Education
  • Educated to degree level in a relevant discipline and/or equivalent work experience

Language Skills
  • Excellent communication skills both verbal and written

Required skills and experience:
  • 5 plus years proficiency in SAS programming
  • 2+ years of ADaM, CDISC or SDTM
  • Lead experience in a Pharma setting
  • Attention to detail, ability to be self-driven and solid organization skills
  • Excellent communication skills (verbal and written)

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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