Senior Statistical Programmer (FSP), Georgia, Poland, Serbia, Hungary

Parexel

$80K — $95K *
US-AnywhereRemote in Georgia, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences required.
  • Minimum of 5 years of clinical/statistical programming experience in pharmaceutical development.
  • Proficiency in SAS programming; experience with R is a plus.
  • In-depth understanding of clinical data structures including CDISC standards.
  • Experience with processing upstream data forms and meeting downstream output requirements.

Responsibilities

  • Create SAS programs for analysis datasets and reporting outputs.
  • Provide programming support including strategies, standards, and specifications.
  • Assist with electronic submission preparations and reviews.
  • Review planning documents to ensure clarity and alignment with team objectives.
  • Interact with vendors about project standards and programming specifications.
  • Lead and ensure quality deliverables in compliance with regulatory standards.
  • Identify efficiency opportunities within the team and vendor interactions.

Benefits

  • Fully flexible work arrangement with options for home-based work.
  • Comprehensive induction and training program.
  • Competitive financial packages and professional development opportunities.
  • Support for achieving work/life balance.
  • Multinational team environment focusing on employee welfare.
Full Job Description
Parexel is currently seeking a Senior Statistical Programmer to join us in either Georgia, Serbia, Poland or Hungary, dedicated to a single sponsor.

Picture Yourself At Parexel:

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data.

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.
• Proficiency in SAS is required. Experience with R would be a strong asset.
• Have in-depth understanding of clinical data structure (e.g., CDISC standards) and relational database.
• 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.
• Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.
• Good understanding of regulatory, industry, and technology standards and requirements.
• Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.

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 Georgia/Poland /Serbia/Hungary. We are unable to sponsor or take over sponsorship of an employment Visa.

Similar Jobs

More Jobs at Parexel

More Pharmaceuticals & Biotech Jobs

Find similar Senior Statistical Programmer (FSP), Georgia, Poland, Serbia, Hungary jobs: