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Principal Statistical Programmer
Principal Statistical ProgrammerLancesoft INC • Cambridge, MA, US
Principal Statistical Programmer

Principal Statistical Programmer

Lancesoft INC • Cambridge, MA, US
2 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Under the supervision of the Head of Statistical Programming, the Contractor Statistical Programmer will be assigned to work on a TA / Study at Ipsen.  The contractor will participate in the oversight, creation, maintenance and finalization of clinical study datasets / TFL for Ipsen development programs, and ensure all clinical datasets perform the analysis defined by SAP and meet the standards required for regulatory submissions for all INDs and NDAs / MAAs Main responsibilities / job expectations

  • Responsible for Statistical Programming activities, including analyzing, integrating and reporting of clinicaltrial data in order to produce quality and timely deliverables.
  • Performs data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Provide statistical programming support to generate derived analysis data sets, tables, listings, and figures for Clinical Study Reports, regulatory submissions, annual IND safety update reports and Integrated summaries (ISS / ISE).
  • Creation / QC of CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
  • Interact with Statisticians, Programmers and other members of the clinical team, perform ad hoc analysis and generate outputs according to the requirements.
  • Review and comment on CRFs, annotated CRFs, Data Management Plan, Data validation plan, edit check specifications and study related documents.
  • Participate in operations meetings and address issues that may influence statistical programming and data management.
  • Work with CRO statisticians, statistical programmers and review / QC their work / deliveries.

Knowledge, abilities & experience Education / Certifications :

  • Bachlor’s degree or higher in Statistics, Mathematics, or Scientific Discipline

    • Experience :

  • 5+ years’ programming experience in pharmaceutical / biotech / CRO environment in drug discovery / clinical trials / drug development
  • Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.

    • Languages :

  • Strong verbal and written communication skills (English) with the ability to communicate effectively at different levels of the organization

    • Key Technical Competencies Required

  • Proficiency in statistical programming package(s), SAS is required; R or other packages are desired.
  • Familiar with Global Clinical Data Interchange Standards Consortium (CDISC).
  • Understand clinical data flow.  Experience in NDA submission is desired.
  • Experience in SDTM and / or ADaM specification and programming.
  • Experience in TFL programming.
  • Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment.
  • Good computer literacy

    • Company Description

    We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

    Company Description

    We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

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    Programmer • Cambridge, MA, US