Adaptimmune

SAS/ Statistical Programmer

Biometrics - Philadelphia, PA - Full Time

SUMMARY

The SAS/Statistical Programmer provides SAS programming support to clinical project teams to support the development and regulatory approval and of Adaptimmune Tcell therapies. This position is primarily responsible for the implementation of technical solutions for integrating, analyzing and reporting clinical data, including troubleshooting and recommending computer software code adjustments to create or modify these technical solutions.

KEY RESPONSIBILITIES

  • Create and maintain  programs and utilities in accordance with predefined specifications and Adaptimmune standards
  • Perform data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
  • Generate and validate ADaM datasets/analysis files, and tables, listings, and figures ( TLFs);
  • Production and QC / validation programming
  • Ensure specifications and documentation are correct and complete
  • Troubleshoot and debug  code in non-system analysis & reporting programs to support implementation of technical solutions for integrating and analyzing clinical data
  • Independently perform SAS programming and Analysis support of analysis datasets, listings, summaries, and tables
  • Review and support key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan, eCRF) to ensure alignment with programming objectives and requirements
  • Analyze information and evaluate results to choose the best solution and solve problems
  • Develop standard SAS macros that can be applied repeatedly across different studies
  • Carry out programming in accordance with project standards, programming conventions, programming specifications and file transfers
  • Aggregate datasets from disparate sources and file types and formats within and across studies (for example specialty labs in excel, CSV format with SAS datasets from the EDC) into one cohesive dataset that is ready for use by SAS programmers and statistician’s.  
  • Generate and QC summary tables, logs, data listings, and graphs for a study and validation of the data using SAS standard coding techniques and maintain validation documentation
  • Develop milestones and timelines, relay these objectives to the team, and ensure that the team is successful in obtaining these goals

QUALIFICATIONS & EXPERIENCE

  • Bachelor’s or Master’s degree in statistics, biostatistics, mathematics, and/or computer science required.
  • 3-5 years statistical programming experience in pharmaceutical/biotech or CRO
  • Proficiency in SAS (Statistical Analysis Software): i.e. Base, Stat, Graph components, with general computing knowledge related to clinical development activities preferred
  • Adept at implementing the latest CDISC SDTM / ADaM standards
  • Strong Knowledge of Oncology including efficacy programming using RECIST 1.1 (ADRS) and time to event (ADTTE)
  • Submissions experience utilizing define.xml and other submission documents strongly desired.
  • Excellent analytical & troubleshooting skills.
  • Ability to provide quality output and deliverables, in adherence with challenging timelines
  • Proven track record of being able to work on multiple studies.
  • Experience supporting programming for regulatory filings (e.g. NDA, BLA, MAA)*
  • Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
  • Project management skills

SKILLS & COMPETENCIES

  • 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
Apply: SAS/ Statistical Programmer
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