[Hiring] Senior Statistical Programmer @Parexel

Role Description

Parexel is currently seeking a Senior Statistical Programmer to join us in either Poland, Hungary, or Serbia dedicated to a single sponsor. This role will provide technical expertise for the conduct of clinical trials, acting as an internal subject matter expert in specific areas providing technical support and expert advice, working independently to support various programming activities related to the analysis and reporting of clinical study data.

Working as a Senior Statistical Programmer at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

• 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.
• Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis.
• Support the electronic submission preparation and review.
• Review 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; assess impact on programming activities.
• Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers.
• Provide leadership for ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and work practices.
• Identify opportunities for increased efficiency and consistency within team and our interactions with strategic vendors.
• Independently lead and/or perform programming assignments with minimal supervision.
• Support improvement initiatives.

Qualifications

• 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.
• 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.

Benefits

• Open and friendly work environment.
• Opportunities to develop long-term careers.
• Opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.
• Fully flexible work arrangement - you can be fully home-based.
• If you live close to our office, you are always welcome to use it, and we will keep the desk ready for you!

Company Description

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.

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.