Clinical SAS Programmer - Pharma/Life Sciences

Designation : Statistical Programmer

Reporting to : BPO 4/5 [Statistical Programmer 3 / Group Head]

Work Location : Mumbai

Night Shift/ Rotational Shifts : General

Educational Qualifications : Life sciences graduate, he/she can be [BSc, BPharm, Engineer, MPharm, MSc].

Desired Experience Level in Years : 2 to 5 years

Major Deliverables : SDTM, and/or Phase I [ADaM/TLFs]

Salary : Best as per capability

- Understand the usage of CDISC SDTM guidance rules to annotate eCRFs with SDTM domains and variables

- Identify the required SDTM domains required based on CRF data

- Identify the protocol specific/standard SDTM domains and assign to CRF

- Developing and Validating SDTM domains

- Creating programs using SDTM & SAS CRFs

- Comparing SDTM annotations against approved template annotations

- Developing domains as per latest SDTM standards

- Mapping variables related to Controlled Terminology

- Define QC & Validation of SDTM mapping

- Participate in Case Report Form (CRF) review process to make recommendations from a programming/CDISC perspective

- Perform CDISC to CRFs mappings, annotations and create Case Report Tabulations (CRTs) using CDISC SDTM (Study Data Tabulation Model) specifications

- Address ad-hoc programming requests and perform validation tasks

- Develop, share, and document innovative programming techniques for data review

- Review and validate other programmer's work

- Perform and/or initiate comprehensive data management tasks, pertaining to Database Design, Programming, Validation and Data transfers

- Perform quality control procedures for Database Design and Database Programming

- Assist in developing and implementing new technology in Database Design

- Develop and maintain good communications and working relationships within team

- Perform tasks/activities as communicated by Lead

- Attend telephone conferences/meetings as required

- Adherence to SOPs/Regulatory requirements/project specific guidelines

- Escalation of identified unresolved issues to Lead on time

- Provide inputs/status reports on monthly basis during the tenure of life cycle of the project

Training :

- Train the team on SDTMv specifications

The operational techniques and activities undertaken within the Clinical Data Management Unit

- Clinical Data Management SOPs and other standards

- Undertake training related to a project to CDM team members