SAS/ Statistical Programmer

Adaptimmune

Abingdon, UK

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The SAS/ Statistical Programmer provides SAS programming support to clinical project teams to support the development and regulatory approval and of Adaptimmune Tcell therapies.

The position will be responsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions.

The incumbent will work closely with Biostatisticians to create SAS programs for independently validating selected tables, listings, and figures produced by programming vendors, for adhoc analyses, and safety review. This position will also serve as a contact for programming activities being performed at CROs. Oncology experience a plus.

Key Responsibilities

  • Create and maintain programs and utilities in accordance with predefined specifications and Adaptimmune standards
  • Troubleshoot and debug code in non-system analysis & reporting programs to support implementation of technical solutions for integrating and analyzing clinical data
  • Apply knowledge of the drug development process, clinical trial methodology, and common statistical terminology to support validation of clinical data
  • Deliver clinical data analysis to development teams (including in stream reviews) and assess reporting requirements using common practices
  • Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan, eCRF) to ensure alignment with assignment objectives and requirements
  • Review and approve SAS programming instructions and CDISC/ADaM specifications
  • Carry out programming in accordance with project standards, programming conventions, programming specifications and file transfers
  • Assess processes and procedures involved to bring together disparate inpatient datasets (including across studies) into one cohesive dataset that is ready for use by analysts.
  • Generate and QC summary tables, logs, data listings, and graphs for study and validation of the data using SAS standard coding techniques.

Qualifications & Experience

Required

  • Bachelor’s or Master’s degree in statistics, biostatistics, mathematics, and/or computer science required.
  • Solid experience in statistical programming experience in pharmaceutical/biotech or CRO, or Academic environment
  • Proficiency in SAS (Statistical Analysis Software): i.e. Base, Stat, Graph components, with general computing knowledge related to clinical development activities preferred
  • Experience in CDISC and ADaM standards
  • Strong knowledge of oncology including efficacy programming using RECIST

Desirable

  • Some clinical / statistical programming experience related to pharmaceutical clinical development – exposure to significant regulatory filings (e.g. NDA, BLA, MAA)* an advantage
  • Academic environment experience or related coursework
  • Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements including CDISC standards is preferred
  • Project management skills

Skills & Compentencies

Required

  • Works well under pressure and on multidisciplinary, virtual teams.
  • Works independently - self-directed, high energy and strong work ethic.
  • Strong written and verbal communication skills.
  • Ability to adapt effectively to changing priorities.
  • Attention to detail
  • Team player

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