ADDITIONAL REQUIREMENTS:

• Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings.
• Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements.
• Experience in other software packages (e.g., R)
• Experience with the Linux operating system.

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, you are always welcome, and we will keep the desk ready for you!
Applicants must be authorized to work in Romania. We are unable to sponsor or take over sponsorship of an employment Visa.

WHAT YOU’LL DO AT PAREXEL:

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs.
• Provides programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis.
• Support the electronic submission preparation and review.
• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities.
• Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers.
• Provides leadership for ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices.
• Identifies opportunities for increased efficiency and consistency within team and our interactions with strategic vendors.
• Independently leads and / or performs programming assignments with minimal supervision.
• Support improvement initiatives.

ROLE REQUIREMENTS:

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development.
• Demonstrated proficiency in analytical programming.
• 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 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.
• Have good understanding of regulatory, industry, and technology standards and requirements.
• Have good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
• Demonstrated ability to work in a team environment with clinical team members.