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.
Here are a few requirements specific to this advertised role
Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
Proficiency in SAS.
Several years of 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 databases.
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.
Good understanding of regulatory, industry, and technology standards and requirements.
Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
Demonstrated ability to work in a team environment with clinical team members.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
Who are Parexel
Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many 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!
Base Pay Range for Poland: PLN 200,000 - 260,000
Depending on the position offered, employees may be eligible for incentive plans, bonuses, and/or other forms of compensation, in addition to health, welfare, and other employee benefits.
