Senior Statistical Programmer - Serbia - FSP

Parexel is currently seeking a Senior Statistical Programmer to join us in either Serbia or Poland, 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.

Responsibilities

• 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.

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.

• 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 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.

• 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.

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.

You’ll be an influential member of the wider team.

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!

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