Statistical Programmer II (R Programming) - Poland (Home-based) - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel is currently seeking an R focused Statistical Programmer II to join us in Poland dedicated to a single sponsor.

This role will provide technical expertise for the conduct of clinical trials and works with minimal supervision to support various programming activities related to the analysis and reporting of clinical study data. In addition, the Statistical Programmer II may fill the Statistical Programming Lead role (or part of that role) on small, non-complex projects.

Working as a Statistical Programmer II at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Base Pay Range for Poland: PLN 166,500 to 225,500.

Actual salaries may vary within the range based on several factors including, but not limited to education, training, experience, professional achievement, and location.

In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan, annual salary review and total rewards incentives.

Our talent acquisition team will provide additional details on our bonus plan or incentive programs for those eligible roles.

Responsibilities

• Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.

• Check own work in an ongoing way to ensure first-time quality.

• Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings.

• Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.

• Maintain and expand local and international regulatory knowledge within the clinical industry.

• Develop knowledge of SAS and processes/procedures within other Parexel functional areas.

• Provide relevant training and mentorship to staff and project teams as appropriate.

• Maintain all supporting documentation for studies in accordance

• with SOPs/Guidelines to ensure traceability and regulator 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 process/quality improvement initiatives.

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

Here are a few requirements specific to this advertised role.

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences.

• Excellent analytical skills.

• Intermediate level of R programming language.

• Knowledge and understanding of the programming and reporting process.

• Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.

• Ability to learn new systems and function in an evolving technical environment.

• Ability to manage competing priorities and flexibility to change.

• Ability to successfully work as part of a global team.

• Effective time management in order to meet daily metrics or team objectives.

• Business/operational skills that include customer focus, commitment to quality management, and problem solving.

• Strong understanding of CDISC standards.

• Knowledge of statistical termin