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Senior Statistical Programmer

  • Job type Contract
  • Salary Negotiable
  • Location Morris Plains, New Jersey
  • Sector Pharma & Biotech

One of Real Staffing's Pharmaceutical clients is seeking a Senior Statistical Programmer to join their team.

Location: Morris County, New Jersey

Contract Duration: 6 Months initial duration - extension or conversion possible

Description:

  • The Senior Statistical Programmer is an independent programmer and analyst responsible for delivery of the technical components required to support the analysis and reporting for various clinical development projects. Expected to provide broad expertise in all aspects of the statistical programming field. Critical project activities include reporting dataset development, statistical and clinical reporting, validation and submissions support.

Responsibilities:

  • Provide clinical data management and biostatistical programming support for various phases of clinical studies;
  • Assist in the production and QC of analysis plans, TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents;
  • Independently, perform SAS programming and analysis support of analysis datasets, listings, figures, and summary tables according to specification and mock shell;
  • Ensure quality control (QC) performed on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with company quality standards, ICH-GCP and/or other international regulatory requirements;
  • Provide programming support to the regulatory submissions including data submission package and define.xml development;
  • Communicate effectively within a multi-disciplinary project team to complete assigned tasks on time and with high quality;
  • Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.);
  • Reviews and makes recommendations for process development and improvement. Contribute to the development of best practice to improve quality, efficiency and effectiveness.

Requirements:

  • Bachelor's degree in life science, statistics, mathematics, computer science, or related field required; Master's degree preferred.
  • 5+ years of SAS programming experience in biotech or pharmaceutical industry.
  • Solid knowledge and experience of CDISC standards including SDTM and ADaM,
  • Strong competence in SAS/Base, SAS/Macro, and SAS/STAT programming;
  • Oncology therapeutic area and submission experience is preferred.
  • Detail oriented and strong organizational and communication skills.
  • Ability to work in a team environment.

Sthree US is acting as an Employment Business in relation to this vacancy.