Senior Statistical Programmer

TATA CONSULTANCY SERVICES ASIA PACIFIC PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A leading global consultancy firm in Singapore is seeking a Sr Statistical Programmer with over 5 years of experience. The successful candidate will manage customer communications, ensure quality deliverables, and implement process improvements. Proficiency in SAS programming and familiarity with CDISC standards are essential. Candidates with experience at Pfizer will be preferred. An understanding of the clinical guidelines, strong communication, and proficiency in Mandarin are required for this role.

Qualifications

• 5+ years of experience in statistical programming.
• Experience with SAS Base/Macros/GTL.
• Familiarity with CDISC standards SDTM/ADAM.

Responsibilities

• Manage communication with customers.
• Ensure quality on-time deliverables.
• Implement process improvements for efficiency.

Skills

SAS Programming

Statistical programming

Communication

Quality Assurance

Project management

Mandarin proficiency

Tools

SQL

SAS Macros

GTL

Job description

Overview

We are looking for an associate with at least 5+ years of experience for the 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

Additional understanding and expectations

• 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