Senior Statistical Programmer

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FSP (Functional Service Provider) solutions

Job Location:

Key Responsibilities Statistical Programming

• Ensure compliance with applicable

  SOPs

  , the

  Quality Management System (QMS)

  , and

  Good Clinical Practice (GCP)

  .
• Implement and adhere to the latest versions of

  CDISC standards

  ,

  FDA guidelines

  ,

  GCP

  , and other relevant industry regulations.
• Participate in and coordinate the

  Statistical Programming review

  of Case Report Forms (CRFs), annotated CRFs, database structures, and study-related documentation (e.g., data validation guidelines).
• Review and interpret

  Statistical Analysis Plans (SAPs)

  and

  Report Analysis Plans

  , providing feedback and recommendations for assigned projects.
• Develop and review

  SAS programs and outputs

  for:
• Clinical trial data management
• Data tabulations
• Patient data listings
• Graphical outputs
• Derived datasets and statistical analyses as specified in SAPs and RAPS
• Develop SAS programs for

  ad hoc tables, listings, diagnostics, and data review

  in support of Clinical Data Management.
• Perform

  electronic data transfers

  (incoming and outgoing) and develop/review programs to ensure transfers meet specifications.
• Design and implement

  SAS-based utilities and systems

  to support and enhance Clinical Data Management activities.
• Review draft and final production runs to ensure

  quality, accuracy, and consistency

  .
• Provide feedback for the

  continuous improvement of SOPs

  , including BPP and cross-functional procedures.
• Ensure high-quality deliverables for both

  individual work and team outputs

  , particularly when acting as a

  Lead Programmer or Biometrics Project Manager

  .
• Represent Statistical Programming in

  internal project meetings, client meetings, and audits

  .
• With sufficient experience, support senior Statistical Programming staff by contributing to

  effort estimation, cost estimates, and client presentations

  .
• Proactively communicate

  changes in project scope

  to senior staff to support timely development of change orders.
• Demonstrate strong

  problem-solving skills

  , a proactive mindset, and sound decision-making abilities.
• Encourage and participate in

  process improvement initiatives

  within the Statistical Programming function.
• Stay current with

  emerging programming techniques, tools, and IT advancements

  relevant to clinical data management and reporting.
• Perform other duties as assigned by senior Statistical Programming leadership.