Parexel

Senior Statistical Programmer – FSP

Parexel

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇵🇱 Poland

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Job Level

Senior

About the role

  • 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.

Requirements

  • 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 database.
  • 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.
Benefits
  • Competitive financial packages
  • Training and development
  • Fully flexible work arrangement

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
SASanalytical programmingclinical/statistical programmingCDISC standardsrelational databaseADaMData Definition Tablee-submissiondata handlingprogramming validation
Soft skills
leadershipteam collaborationcommunicationproblem-solvingattention to detailefficiency improvementindependenceproject managementstrategic thinkingquality assurance
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