Pharmacometrics (PM) Support Programmer

ACURA SOLUTIONS LTD; Maharashtra; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

ACURA SOLUTIONS LTD is seeking a candidate for a Pharmacometrics role with strong R software skills and PK/PD interest. The candidate will program and QC NONMEM PK/PD datasets and ensure data quality for submissions. English communication is essential, with 4-10 years of industry experience.

Degree in health/science or IT with R knowledge is preferred. The role involves data management collaboration with Data Management, Statistics, and Biostatistics teams; delivery of high-quality results

Qualifications

• Minimum BA/BS degree; health or science field preferred.
• IT degree acceptable if you have R software knowledge.
• 4–10 years of industry experience.
• Strong working knowledge of R software.
• Proficient in English with strong communication.
• Interest in PK/PD and clinical trial concepts.

Responsibilities

• 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.
• Completes programming tasks of medium to high complexity with high quality and timeliness.
• Critically reviews requirements and data to identify gaps and improve efficiency.

Skills

R software

English proficiency

PK/PD interest

Detail oriented

Studious

Education

BA/BS degree

Health or science degree

IT degree with R knowledge

Tools

R

Job description

• Services rendered will adhere to applicable client SOPs,WIs, policies, localregulatoryrequirements,ICH-GCP, etc.
• 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 Pharmacometrics 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.

Deliverables

• Services rendered will adhere to applicable client SOPs,WIs, policies, localregulatoryrequirements,ICH-GCP, etc.
• 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 Pharmacometrics 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: BA/BS
• Degree in a health or science related field. IT degree can also be considered if working knowledge with R software.
• Min. 4 to 10 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.