Remote Lead Statistical Programmer (SDTM/ADaM)

Iqvia; Quilmes; Remote; ARS 138,361,000 - 184,482,000; Full time

Benefits offered by this job

Permanent full-time position

Flexible schedule

Home-based position

Ongoing learning and development

Job summary

Indero seeks a Senior Statistical Programmer to lead and collaborate on multiple clinical trials. You will develop, maintain, and validate aCRFs, SDTMs, and ADaMs per CDISC standards, and ensure quality SDTM/ADaM outputs and submission packages.

You will review SAPs and DM documents, support data cleaning, and leverage Pinnacle 21 for validation. The role requires at least 5 years in clinical research, strong SAS skills, CDISC/CDISC-IG knowledge, and excellent English communication.

Qualifications

• Bachelor’s degree in Statistics, Computing Sciences or a related field.
• At least 5 years of clinical research experience in biotechnology, pharmaceutical or CRO
• Excellent exposure to SAP, TLF Shells, and specifications
• SAS proficiency; SAS certification is an asset
• CDISC standards knowledge; CDISC certification is an asset
• Knowledge of drug development process and ICH guidelines
• Strong organizational and time management skills
• Fluent English; French an asset

Responsibilities

• Act as Lead Statistical Programmer on multiple studies.
• Review and input into SAPs, TLF Shells, and DM documents.
• Develop/maintain/validate aCRFs and SDTMs/ADaMs per protocols.
• Validate SDTMs, ADaMs and define.XMLs using Pinnacle 21.
• Use global SAS macros to improve efficiency.
• Mentor junior programmers.
• Collaborate with Biostatistics and DM teams to ensure quality deliverables.

Skills

SAS programming

CDISC SDTM/ADaM

Clinical trial data

Lead programmer

SAS macros

Quality standards

Communication skills

Education

Bachelor’s in Statistics/Computing Sciences

Master’s degree (asset)

Tools

SAS

XML programming

Job description

Indero seeks a Senior Statistical Programmer to lead and collaborate on multiple clinical trials. You will develop, maintain, and validate aCRFs, SDTMs, and ADaMs per CDISC standards, and ensure quality SDTM/ADaM outputs and submission packages.

You will review SAPs and DM documents, support data cleaning, and leverage Pinnacle 21 for validation. The role requires at least 5 years in clinical research, strong SAS skills, CDISC/CDISC-IG knowledge, and excellent English communication.