Analyst

Job Title

Senior Statistical Programmer

Relevant Experience

(in Yrs)

We are looking for an associate with at least 5+ years of experience for Sr Statistical programming position, having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards

Must Have Technical/Functional Skills

SDTM/ADaM Model and IG

Thorough understanding of SDTM/ADAM concepts and challenges. Good hold on the TAUG's and related guidelines.

Hands on experience in implementing SDTM/ADAM concepts across TA's and various phases of clinical trains. Good understanding on previous versions on SDTM/ADAM guidelines.

Study Reporting

Suggest creative solution approach for various business requirements to solve complex SDTM/ADaM Mapping and Programming problems (e.g. creates modular reusable code, develops standard code or utilities, and designs interconnected programs. Review and author documents related to deliverables (User Guide, CDARS Mapping Specification, OCF, Test Plans, SAS Logs and Programs). Good understanding of all study documents including Protocol, SAP, Mock Shells, LOT, Analysis plan 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.

SAS Programming

Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs.

Development of the complex SAS macros that can be utilized across TAs in multiple studies; review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS and other advanced SAS components. Mentor and supervise developer to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements.

Controlled Terminology

Good understanding of code list and value list concepts. Expertise in managing NCI codelist and tracking its updates. Exposure to CDASH, SDTM/ADaM and ADaM lineage concepts

Other CDISC IG's

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

Hands on exposure in managing few of these activities

Developing Mapping Specs

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

SDTM/ADaM Dataset Programming

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

SDTM/ADaM Compliance Define

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

Validation

Implement QA and QC validation in accordance with Departmental SOP's for deliverables including:

• Formal study reports

• Data review

• Presentations

• Adhoc-requests