Senior Statistical Programmer

About Tech Observer

Tech Observer is a global Contract Research Organization (CRO) providing end-to-end clinical research solutions to pharmaceutical, biotechnology, and medical device companies, including flexible FSP (Functional Service Provider) solutions . Headquartered in New Jersey, USA, Tech Observer operates across the USA, EMEA, and APAC regions, with an established presence in the UK, India, Singapore, Denmark , and 20+ countries worldwide .

Job Location: Ahmedabad/Mumbai/Hyderabad/Noida

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.