Molecular Connections - Statistical Programmer Molecular Connections

3.0 - 5.0 years

2 - 6 Lacs

Bengaluru

Work from Office

Position Overview : We are seeking a skilled Statistical Programmer to join our clinical research team. The successful candidate will be responsible for programming, validating, and delivering statistical outputs for clinical trials while ensuring compliance with regulatory standards and industry best practices. Key Responsibilities : Programming & Data Management : - Develop and maintain SAS programs for clinical trial data processing, analysis, and reporting. - Map clinical trial data to CDISC standards (SDTM and ADaM) ensuring compliance with regulatory requirements. - Create and maintain analysis datasets following CDISC implementation guidelines. - Perform data validation and quality control checks to ensure data integrity. Documentation & Compliance : - Generate and maintain CDISC documentation including define.xml files, reviewer's guides, and annotated case report forms (aCRF). - Conduct Pinnacle21 validation checks and resolve any compliance issues. - Ensure all deliverables meet regulatory submission standards (FDA, EMA, etc.). - Maintain comprehensive programming documentation and version control. Statistical Analysis & Reporting : - Produce Tables, Listings, and Figures (TLFs) based on Statistical Analysis Plans (SAP). - Collaborate with biostatisticians to implement complex statistical analyses. - Support clinical study reports and regulatory submissions. - Perform ad-hoc analyses as requested by clinical teams. Cross-functional Collaboration : - Work closely with clinical data management, biostatistics, and regulatory affairs teams. - Participate in project meetings and provide technical expertise. - Support timeline planning and deliverable tracking. - Mentor junior programmers and provide technical guidance. Required Qualifications : Technical Skills : - Minimum 3+ years of experience as a statistical programmer in clinical research or pharmaceutical industry. - Advanced SAS programming skills with expertise in Base SAS, SAS/STAT, SAS/GRAPH, and SAS Macro language. - Strong understanding of clinical trials including study designs, endpoints, and regulatory requirements. - Proven experience with CDISC standards (SDTM and ADaM) and data mapping techniques. - Experience with CDISC documentation including define.xml, reviewer's guides, and aCRF preparation. - Hands-on experience with Pinnacle21 validation software and resolving compliance issues. - Demonstrated ability to produce TLFs based on Statistical Analysis Plans with attention to detail. Soft Skills : - Fluent in English with excellent written and verbal communication skills. - Strong problem-solving mentality with ability to troubleshoot complex technical issues. - Detail-oriented approach with commitment to accuracy and quality. - Excellent communication and interpersonal skills for effective team collaboration. - Fast learner with ability to adapt to new technologies and methodologies. - Strong organizational skills and ability to manage multiple priorities. Preferred Qualifications (Nice to Have) : - Real-World Data (RWD) experience including analysis of electronic health records, claims data, or registries. - Pharmacokinetic (PK) calculations experience and understanding of PK/PD modeling. - R programming skills for statistical analysis and data visualization. - Experience with other statistical software packages (Python, SPSS, etc.). - Knowledge of therapeutic areas and regulatory guidelines. - Experience with cloud-based platforms and version control systems. Education Requirements : - Bachelor's degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field. - Advanced degree preferred but not required with relevant experience. This position offers an excellent opportunity for a skilled statistical programmer to contribute to meaningful clinical research while developing expertise in regulatory compliance and industry best practices.

Posted 5 days ago

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