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.