Job Description

Company: TK-Chain (www.tk-chain.com) Position: Senior Statistical Programmer Location: Hyderabad, Chennai Experience: 5+ years in Pharmaceutical, Biotech, or CRO industry Job Overview: We are searching for an experienced Senior Statistical Programmer to join our dynamic team at TK-Chain. As a Senior Statistical Programmer, you will play a critical role in the development, quality control, and documentation of statistical programming deliverables for clinical research studies. If you have a strong background in SAS programming, clinical trial data, and a passion for ensuring data accuracy and quality, we encourage you to apply. Key Responsibilities: Lead and Oversee SAS Programming : Take the lead in developing SAS programs for the management and statistical analysis of clinical trial data. Statistical Tables and Listings : Develop, test, and validate statistical tables, listings, and graphs (TLGs) in accordance with the statistical analysis plan. Document Review : Support the generation and review of protocols, data management plans, study reports, and other regulatory documents. Statistical Planning : Provide input to the statistical analysis plan, table shells, data integration plans, and mock-ups. Data Quality Assurance : Ensure data quality by designing and validating key data checks and listings. Data Transformation : Develop specifications for derived datasets and perform data transformation as necessary. Collaboration : Collaborate effectively with data management and biostatistics teams, clinicians, and other project stakeholders. Mentorship : Guide junior programmers and provide mentoring as needed. Subject Matter Expertise : Stay up-to-date with new developments in SAS programming and clinical research, and act as a subject matter expert for the team. Required Qualifications and Skills: Educational Background : Bachelor\'s or master\'s degree in Statistics, Mathematics, Computer Science, or a related field. Industry Experience : Minimum of 5 years of statistical programming experience in the pharmaceutical, biotech, or CRO industry. SAS Proficiency : Excellent SAS programming skills, including SAS/Base, SAS/Macro, SAS/Graph, and SAS/STAT. CDISC Standards : Familiarity with CDISC SDTM and ADaM data standards. Clinical Trial Knowledge : In-depth understanding of clinical trial data and complex statistical methods. Problem-Solving : Excellent problem-solving skills and a proactive approach to identifying and resolving issues. Communication : Strong written and verbal communication skills, with the ability to translate complex data into understandable results. Language : Proficiency in English, with excellent written and verbal communication skills. Leadership Experience : Prior experience leading teams or projects is highly desirable. Preferred Skills: Therapeutic Area : Experience in oncology, immunology, respiratory, infectious diseases, or neurosciences is a plus. Other Statistical Software : Knowledge of other statistical software such as R or Python is a plus. Regulatory Guidelines : Knowledge of regulatory guidelines (FDA/EMA/ICH) is preferred.

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