Job Description
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 (eg, 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.
