Senior Statistical Programmer, Poland

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Senior 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 Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Key Accountabilities:

Project Management:

• Ability to fill Statistical Programming Lead role on projects

• 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.

• 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:

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

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

Ideal candidate will possess:

• Excellent analytical skills.

• Proficiency in SAS.

• Life science industry experience.

• Extensive 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.

• Strong project management skills.

• Strong organizational skills, ability to manage competing priorities, and flexibility to change.

• Ability to successfully lead a global team.

• Competent in written and oral English.

• Excellent communication skills.

• University degree level in a relevant discipline.

A little about us:

Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program.We offer a friendly and supportive working atmosphere; we cooperate within projects, help each other, and achieve results as a one team. We compete in running, riding a bike and burning calories!Benefit package that includes private medical care at LUX MED, life assurance, Cafeteria system, lunch vouchers and more!Parexel has a fully flexible work arrangement - you can be fully home based. But if you live close to our Warsaw office (Business Garden Complex) and you want to use it, great, you are always welcome, and we will keep the desk ready for you!