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

We are hiringa 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

Statistical Programmer – 20 positions (3 Managers)

1. ADaM (Analysis Data Model) + TLF (Tables, Listings, and Figures) + R Programming – 5 Positions

2. SDTM (Study Data Tabulation Model) + Metadata + CDISC Standards – 5 Positions

3. Clinical SAS Programmer – 5 Positions

6+ Years of relevant experience and total could be more.

JD:

Statistical Programming Services

Skills, Knowledge, and Experience

Minimum Requirements:

• Bachelor's 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

Please let me know if you are interested in this position and send me your resume to [HIDDEN TEXT]