Senior Statistical Programmer — Fully Remote (SAS Expert)

Parexel; Polska; Remote; PLN 200,000 - 260,000; Full time

Benefits offered by this job

Fully remote

Job summary

Parexel is seeking a Senior Statistical Programmer to join us in Poland (or Romania, Hungary or Serbia) on a flexible basis. You will provide expert programming for clinical trials, support submissions, and act as a SME in SAS and CDISC standards.

The role offers strong long-term prospects, with opportunities to grow within Parexel FSP and work with leading sponsors. The position emphasizes independence, collaboration, and adherence to regulatory standards, while enabling fully home-based work

Qualifications

• Bachelor's degree in statistics, biostatistics, mathematics, computer science or life sciences.
• Proficiency in SAS.
• Several years of clinical / statistical programming experience in pharma.
• In-depth understanding of CDISC standards and relational databases.
• Experience with Pinnacle 21, MS Office and XML.
• Ability to handle upstream data (e.g., SDTM, ADaM) and produce submissions.
• Ability to work in a team and independently within Parexel FSP.

Responsibilities

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; perform validation.
• Provide programming support for project teams, including strategies and standards.
• Support electronic submission preparation and review.
• Review planning documents to ensure alignment with objectives and clear programming requirements.
• Interact with vendors regarding standards, conventions, specifications and transfers.
• Lead to ensure quality of deliverables and regulatory compliance.
• Identify opportunities for efficiency and consistency within the team.

Skills

SAS

Clinical programming

CDISC standards

Analytical programming

Team collaboration

Education

Bachelor's degree

Tools

Pinnacle 21

MS Office

XML

Job description

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

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.

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.