Pharmacometrics Support programmer

IQVIA; Coimbatore District; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

IQVIA seeks a Pharmacometrics Support programmer to assist the global PM modelling team in delivering high quality PK/PD NONMEM datasets and QC activities. You will collaborate with Data Management, Statistical Programming and bio-analytical teams to ensure data integrity and timely delivery.

Responsibilities include programming and QC of NONMEM datasets, maintaining SDTM/ADAM standards, and developing robust R-based tooling to support standardization efforts while pursuing continuous process

Qualifications

• Bachelor's degree in health/science or IT with R knowledge.
• Minimum 3 years industry experience.
• Strong R programming and PK/PD understanding.
• Experience with SDTM/ADAM and controlled terminology.

Responsibilities

• Clear communication with partnering departments: Data Management, Statistics, Statistical Programming and Bio-analytical providers.
• Ensures quality NONMEM input data is provided to the PM Leaders within timelines for low to medium complexity projects.
• Keeps oneself inspection ready and knowledgeable for current work by complying with training requirements.
• Programming and QC of NONMEM PK/PD datasets based on SDTM/ADAM datasets.
• QC of outsourced NONMEM datasets.
• Prepare submission projects per internal PM guideline.
• QC of existing, customized R packages for standardization of Pharmacometric works.
• Completes programming tasks of medium to high complexity with high quality and timeliness.
• Actively reviews requirements and data to identify gaps and suggests solutions to improve efficiency.

Skills

Attention to detail

English communication

PK/PD concepts

Data analysis

SDTM/ADAM concepts

NONMEM workflow

R programming

Education

Any Graduation

Health or science related field

IT degree with R knowledge

Tools

R

Job description

Job Title: Pharmacometrics Support programmer

Experience: 3 to 10 years

Location : Across PAN India

JD

The Pharmacometrics (PM) Support Programmer provides support to the global Pharmacometrics modelling team within Clinical Pharmacology & Pharmacometrics in delivering high quality PK/PD NONMEM datasets. Services also include quality control of the NONMEM datasets, and QC of customized R packages created for the department. Datasets are created both before (unclean data) and after database lock.This function liaises closely with Data Management, Statistical Programming, and bio-analytical teams. Services are delivered by applying efficient R programming skills and knowledge of basic PK/PD concepts.

Deliverables:

• Clear communication with partnering departments: Data Management, Statistics, Statistical Programming and Bio-analytical providers.
• Ensures quality NONMEM input data (accurate, valid and complete) is provided to the Pharmacometrics Leaders within projected timelines for low to medium complexity projects.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
• Programming and QC of NONMEM PK/PD datasets based on SDTM/ADAM datasets.
• Follow up and QC of outsourced NONMEM datasets.
• Prepare submission projects per internal PM guideline.
• QC of existing, customized R packages used for standardization of Pharmacometric works (build testing suite of customized packages).
• Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables.
• Critically reviews requirements and data, identifies gaps, suggests solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Involved as active driver in development of new PM standardization efforts.

Education and Experience Requirements/Qualifications:

• Minimum degree: Any Graduation
• Degree in a health or science related field. IT degree can also be considered if working knowledge with R software.
• Min. 3 years industry experience.
• Strong working knowledge of R software (important)
• Interest in PK/PD and clinical trial concepts.
• Studious and data driven person. Eye for detail is very important.
• Proficient in speaking and writing in English. Effective communication skills, oral and written.
• Knowledge of SDTM, ADAM and controlled terminology concepts.
• Knowledge op PK/PD principles
• Previous experience in applying standardization efforts for NONMEM file creation, submission, and QC.