Senior Statistical Programmer

Innovaderm Research Inc.

. Lead single and/or multiple clinical trials as a Senior Statistical Programmer.

Posted 9/15/2026full-timeRemote • ArgentinaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical programming for clinical trials, including proficiency in SAS and knowledge of CDISC standards. Capable of leading projects, mentoring junior staff, and ensuring compliance with regulatory requirements.

Highest-signal resume keywords

Statistical ProgrammingSAS ProgrammingCDISC StandardsClinical Trial Data ManagementLead Statistical Programmer Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical ProgrammingSASXML ProgrammingSDTM DatasetsADaM DatasetsCase Report FormsStatistical Analysis PlansData Monitoring Committee ReviewsDefine.XML/PDF FilesData Cleaning

Soft Skills

Project PlanningTime ManagementCommunication SkillsDetail-OrientedTeam Collaboration

Tools & Technologies

Pinnacle 21Statistical Software

Certifications & Qualifications

SAS CertificationCDISC Certification

Industry Keywords

Clinical TrialsBiotechnologyPharmaceuticalContract Research OrganizationICH GuidelinesHealth Canada RegulationsFDA Regulations

About the role

Key responsibilities & impact

Lead single and/or multiple clinical trials as a Senior Statistical Programmer.
Develop, maintain, and validate annotated Case Report Forms (aCRFs).
Develop and maintain specifications and perform statistical programming for SDTM datasets, ADaM datasets or derived datasets, Tables, Listings, and Figures (TLFs).
Prepare submission packages for Data Monitoring Committee (DMC) reviews, Interim Analyses (IAs), Clinical Study Reports (CSRs), and other purposes.
Review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and Data Management documents such as eCRFs and edit checks.
Support data cleaning activities by programming, reporting, reviewing, and closing statistical data issues.
Develop and validate SDTM and ADaM define.XML/PDF files and reviewer guides.
Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21.
Use global SAS macros to improve statistical programming efficiency.
Act as an Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and interim analyses.
Collaborate with Biostatistical study teams and cross-functional departments to deliver high-quality work within timelines and budget.
Mentor junior Statistical Programmers as needed.
Participate in internal initiatives involving standard macros, templates, programming standards, and processes.
Keep current with industry, CDISC, ICH, and regulatory standards and requirements.

Requirements

What you’ll need

Bachelor’s degree in Statistics, Computing Sciences or a related field; master’s degree an asset.
At least 5 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 4 years of Statistical Programming and 1 year acting as a Lead Statistical Programmer.
Excellent exposure to clinical trial data, SAP, TLF Shells, and specifications.
Excellent working knowledge of SAS; SAS certification an asset.
Knowledge of XML programming an asset.
Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset.
Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP.
Very organized and detail-oriented, with effective project planning and time management skills.
Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands.
Must be able to work independently and as part of a team.
Strong verbal and written communication skills in English; French an asset.
Must be legally able to work in Argentina.

Benefits

Comp & perks

Permanent full-time position
Flexible schedule
Home-based position
Ongoing learning and development
Attractive advancement opportunities
Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request