Senior Statistical Programmer - Clinical SAS/CDISC

About the Company : Greetings from Teamware Solutions a division of Quantum Leap Consulting Pvt. Ltd. Teamware Solutions (a division of Quantum Leap Consulting Pvt. Ltd.) is a 20+ year industry leader providing IT staffing and consulting services, supporting 4000+ professionals across India, the USA, the Middle East, and APAC for leading GCC clients. About the Role : Role : Senior Statistical Programmer Clinical SAS / CDISC. Locations : PAN India. Work Model : Remote (Bangalore and Hyderabad are preferred). Experience : 6+ Years. Notice Period : Immediate 15 days. Job Description : Minimum Requirements : - Bachelors degree in statistics, biostatistics, mathematics, computer science or life sciences required. - At least 6 years programming experience in clinical industry recommended. - Demonstrated proficiency in analytical programming. - Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database. - Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21. - Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. - Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission. - Have good understanding of regulatory, industry, and technology standards and requirements. - Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. - Demonstrated ability to work in a team environment with clinical team members. Preferred Requirements : - Minimum of 6 years clinical / statistical programming experience within pharmaceutical clinical development Supporting regulatory filings (e.g. NDA, BLA, MAA). - Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements. - Experience in other software packages (e.g. R). - Experience with the Linux operating system.