Senior Clinical SAS Programmer

Role: Senior Clinical SAS Programmer

Work Location: Hyderabad/Bangalore/Mumbai/Pune/Delhi/Kolkata

Experience Range: 5 to 12 years in ADaM, TLF

Job Description:

• Thorough understanding of ADAM concepts and challenges. Good hold on the TAUG’s and related guidelines.

• Hands on experience in implementing ADAM concepts across TA’s and various phases of clinical trains.

• Good understanding on previous versions on ADAM guidelines

• Good understanding of all study documents including Protocol, SAP, Mock Shells, LOT, Analysis plan, specifications etc. Hands on experience of development and review of study specific tables, listings and figures for various phases of clinical trials and across TA’s.

• Expertise in Base and Advance SAS programming. Expertise in developing global macros and developing system level concepts and programs.

• Development of the complex SAS utilities; review of the developed SAS programs.

• Expertise in SQL, Macros, Functions and other advanced SAS components. Mentor and supervise developer to build generic standard utilities and SAS codebase, generic listings or other ad-hoc requests in accordance with business requirements

• Exposure to Medical Device, Associated Patients, Oncology and other specific guidelines around CDISC SDTM/ADaM.

• Hands-on experience in developing mapping specs for SDTM/ADaM. Desirable to have hands-on experience in developing mapping specs for a TA or global level SDTM/ADaM mappings.

• Senior Statistical Programmer is responsible for review of developed SDTM/ADaM mapping specifications

• Hands on experience in generating SDTM/ADaM datasets using SAS programming or other tool-based approach

Hands-on experience generating define.xml files, experience in performing SDTM/ADaM compliance checking using P21 or other compliance checks.

• Implement QA and QC validation in accordance with Departmental SOPs for deliverables including: Formal study reports, Data review, Presentations