Senior SAS Programmer

2 weeks ago

Cambridge, United States IntePros Full time

RESPONSIBILITIES:

  • Provide subject matter expertise in designing and developing clinical trials, protocols, and case report forms.
  • Offer technical support and expert advice to internal and external sponsors.
  • Lead and influence ongoing clinical studies by supporting statistical and non-statistical analyses.
  • Implement programming and project standards in accordance with the Statistical Analysis Plan.
  • Act as a liaison between clinical management, subcommittees, and project teams.
  • Use efficient programming techniques to produce and quality-check derived datasets, tables, figures, and data listings.
  • Convert program specifications into SAS code for datasets and outputs.
  • Lead overall project delivery, including clinical trial reports and regulatory submission deliverables.
  • Create statistical analysis outputs for final reports, abstracts, posters, manuscripts, and other clinical publications.
  • Assist in establishing standardized programming procedures and work instructions.
  • Develop, evaluate, and validate standardized macros and utility programs.
  • Assist in developing client proposal documents.
  • Provide leadership, project management, and resource management for programming tasks supporting clinical trial activities.
  • Provide input into statistical programming timelines and negotiate timelines.
  • Mentor statistical programmers and provide input into documents produced by other functions.
  • Keep updated on statistical programming techniques and technical advancements.
  • Interact with regulatory agencies regarding electronic submission specifications.
  • Monitor project resourcing, budgets, and scope changes.
  • Ensure the quality, traceability, and timeliness of programming deliverables.
  • Participate in process/quality improvement initiatives.
  • Provide consultancy to internal and external sponsors on statistical programming tasks.
  • Ensure compliance with relevant regulatory requirements.

EDUCATION:

  • Bachelors degree in Computer Science, Mathematics, Statistics, Life Sciences, or related field.

EXPERIENCE:

  • Minimum of 6 years of experience using SAS in clinical trials data analyses.
  • Exposure to CDISC (SDTM and ADaM) is a plus.

SKILLS:

  • Expertise in SAS/BASE, SAS/STAT, SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS.
  • Knowledge of SDTM, ADaM, FDA and ICH guidance.
  • Understanding of Code of Federal Regulations (CFR) Title 21, Part 11.
  • Strong organizational and time management skills.
  • Consistent experience as a lead statistical programmer.
  • Excellent analytical and presentation skills.
  • Proven ability to learn new systems and function in an evolving technical environment.
  • Ability to negotiate, influence, and create strategies to improve efficiency.
  • Business awareness and financial acumen.
  • Ability to work effectively in a quality-focused environment.

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