SAS Programming: Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures. Perform programming validation to ensure the quality of analysis datasets and programming outputs i.e. Validate Safety and Efficacy Analysis Datasets in adherence with CDISC and client specific standards and maintain quality and accuracy. Project Support: Provide programming support for project teams, including the development of programming strategies, standards, specifications, and programmed analysis. Submission Preparation: Support the preparation and review of electronic submissions. Experience in writing programming specifications for SDTM and ADaM. Document Review: Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements. Assess the impact on programming activities. Vendor Interaction: Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers. Efficiency Improvement: Identify opportunities for increased efficiency and consistency and interactions with strategic vendors. Skills, Knowledge, and Experience: Education: Bachelors degree in statistics, biostatistics, mathematics, computer science, or life sciences. Experience: At least 8 years of programming experience in the clinical industry. Analytical Programming: Demonstrated proficiency in analytical programming. Clinical Data Structure: In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases. Data Handling: Demonstrated ability in handling and processing upstream data (e.g., multiple data forms, workflow, eDC, SDTM). Output Provision: Demonstrated ability in providing outputs to meet downstream requirements (e.g., ADaM, Data Definition Table, e-submission). Regulatory Knowledge: Good understanding of regulatory, industry, and technology standards and requirements. Statistical Knowledge: Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs. Very strong SAS programming skills required in SAS/Base, PROC SQL, SAS/Stat, SAS Macros and SAS/Graph (Base and Advance SAS).
We are seeking an experienced Clinical Trial Manager (CTM) to lead the execution of Phase I, II and III oncology studies at key national institutions in India. This role is pivotal in driving site activation, regulatory compliance, and clinical delivery in alignment with global sponsor expectations. Key Responsibilities: Lead clinical operations and site-level engagement for assigned Phase s studies in India Manage relationships with Principal Investigators (PIs), CRCs, and Institutional stakeholders at government hospitals Oversee timely and compliant PSSV, site initiation visits (SIV), patient recruitment, and data collection Ensure study milestones are met, including First Patient First Visit (FPFV) and clean database targets Collaborate with sponsor teams, regulatory consultants, and third-party vendors to streamline dossier submissions and audit readiness Coordinate regulatory submissions and ethics committee (EC) approvals; ensure alignment with CDSCO, ICMR, and local EC timelines Conduct ongoing risk assessment and drive mitigation strategies across sites Provide oversight to field CRAs and monitor site compliance Contribute to internal SOP development and quality initiatives Key Qualifications: bachelors degree in life sciences or related field; advanced degree preferred Minimum 6-8 years of clinical research experience with at least 3 years in an independent CTM role Demonstrated experience in oncology or immunotherapy trials, preferably with exposure to AIIMS or government research centers Strong working knowledge of GCP, ICH, and CDSCO guidelines Proven track record managing multi-site studies and remote monitoring teams Excellent interpersonal, communication, and problem-solving skills Proficiency in CTMS, EDC, and eTMF systems is a plus Willingness to travel across India as needed (up to 25%)