Project Management

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

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 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.

Training

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

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

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 process/quality improvement initiatives.

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

Ideal candidate will possess:

• Proficiency in SAS.

• Experience in Clinical Research (CRO/Pharma/Biotech/Academia).

• Experience in 4GL 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.

• Attention to detail with a focus on quality.

• MSc/PhD degree in statistics, econometrics, mathematics, informatics.

• Excellent analytical skills.

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

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

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

• Show commitment to and perform consistently high-quality work.

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

A little about us:

Highly qualified and dynamic team. Multinational working environment. Smooth induction and training program. We offer competitive financial packages, training, and development. Expect exciting professional challenges but with a healthy work/life balance. We value your welfare just as highly as that of our patients.

Parexel has a fully flexible work arrangement - you can be fully home based. But if you live close to our office and you want to use it, great, you are always welcome, and we will keep the desk ready for you!

Applicants must be authorized to work in Serbia. We are unable to sponsor or take over sponsorship of an employment Visa.