Senior Statistical Programmer (FSP) - Poland

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

At Parexel FSP people make a difference. We have a crucial mission : to prevent and cure disease by delivering important new medicines and therapies to patients in need. We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.

Parexel is currently seeking a Senior Statistical Programmer to join us in Poland, dedicated to a single sponsor.

Picture Yourself At Parexel :

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.

What You'll Do At Parexel :

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.

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.

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 SAS and processes / procedures within other Parexel functional areas.

Provide relevant training and mentorship to staff and project teams.

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.

Represent Parexel at sponsor marketing and technical meetings.

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 :

Proficiency in SAS.

Proven clinical / statistical programming experience within pharmaceutical clinical development.

Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.

Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.

Demonstrated proficiency in analytical programming.

Excellent analytical skills.

Have in-depth understanding of clinical data structure (e.g., CDISC standards) and relational database.

Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.

Demonstrated ability to work in a team environment with clinical team members.

Strong project management skills.

Good business awareness / business development skills (including financial awareness).

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

Competent in written and oral English.