Job Description

Requirement:

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. He/She should be able to manage communication with customers, track and ensure quality on-time deliverables, suggest and drive implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Pfizer past experience is preferred. Below are the list of expertise areas needed to support our client in the current project:

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 IGs


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




Along with this the candidate must have good understanding of:


Exposure to software development or global macro development process Exposure in developing user specifications, developing global macros, unit testing Experience in handling development and maintenance projects Change Management and Version control process Clinical guidelines understanding like ICH-GCP, SDTM/ADAM IGs etc. Client management, communication, project management and other soft skills Good team player

Proficiency in Mandarin language