Senior Technical Program Manager

About the job

Job Title: The primary responsibility of the Senior Technical Program Manager is to oversee and execute all statistical programming activities in Oncology clinical trials. Key Responsibilities: • Develop, validate, and maintain SDTM/ADaM datasets, TLFs (Tables, Listings & Figures) and submission-ready outputs. • Perform end-to-end statistical programming activities across all phases of Oncology clinical trials. • Support integrated analysis activities for ISS and/or ISE as part of regulatory submissions. • Conduct safety and efficacy analyses including AE summaries, lab evaluations, exposure-response analysis, and time-to-event outputs. • Develop edit checks, data review listings, and derive specifications aligned with study requirements. • Prepare programming specifications, data mapping documents, and validation checks. • Collaborate with Biostatistics, Data Management, Medical Writing and Regulatory teams to ensure timely and quality deliverables. • Ensure compliance with CDISC standards, regulatory guidelines and company SOPs. • Support automation, process optimization, and QC initiatives for continuous improvement. Required Qualifications & Skills: • Bachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline. • 7 years of hands-on Statistical Programming experience in clinical trials (Oncology domain preferred). • Strong working knowledge of ISS or ISE programming submissions. • Expertise in creating safety and efficacy analysis outputs and submission packages. • Experience in edit checks development, dataset specifications and derivation logic writing. • Strong problem-solving, analytical and documentation skills. • Ability to work independently along with effective stakeholder communication.

Requirements

• Statistical Programming
• Oncology Clinical Trials
• CDISC standards
• Data Management
• Analytical Skills

Qualifications

• Bachelor's/Master's degree
• Statistical Programming experience

Preferred Technologies

• Statistical Programming
• Oncology Clinical Trials
• CDISC standards
• Data Management
• Analytical Skills