Jeux de donnees SDTM * Jeux de donnees ADaM * Tableaux, listings et figures (TLF) * Veiller a ce ... The Principal Statistical Programmer will serve as a subject matter expert, ensure highquality ...
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Jeux de donnees SDTM * Jeux de donnees ADaM * Tableaux, listings et figures (TLF) * Veiller a ce ... The Principal Statistical Programmer will serve as a subject matter expert, ensure highquality ...
New
Jeux de donnees SDTM * Jeux de donnees ADaM * Tableaux, listings et figures (TLF) * Veiller a ce ... The Principal Statistical Programmer will serve as a subject matter expert, ensure highquality ...
New
Premier Research is looking for a Senior R Programmer/ Shiny Developer to join our Biostatistics ... SDTM and ADaM review; Dataset comparison; Metadata review; TLF review and quality control; Clinical ...
Premier Research is looking for a Senior R Programmer/ Shiny Developer to join our Biostatistics ... SDTM and ADaM review; Dataset comparison; Metadata review; TLF review and quality control; Clinical ...
Toronto, ON · Remote
CA$170/hr
Simulate raw patient-level data and transform it through SDTM and ADaM into TLF outputs. Ensure every figure reconciles back to its source. * Execute end-to-end analysis pipelines and component tasks.
Quick apply
Toronto, ON · Remote
CA$170/hr
Simulate raw patient-level data and transform it through SDTM and ADaM into TLF outputs. Ensure every figure reconciles back to its source. * Execute end-to-end analysis pipelines and component tasks.
CA$120 - CA$170/hr
Simulate raw patient-level data and transform it through SDTM and ADaM into TLF outputs. Ensure every figure reconciles back to its source. * Execute end-to-end analysis pipelines and component tasks.
Quick apply
CA$120 - CA$170/hr
Simulate raw patient-level data and transform it through SDTM and ADaM into TLF outputs. Ensure every figure reconciles back to its source. * Execute end-to-end analysis pipelines and component tasks.
$17.07 - $22.36
4% of jobs
$22.36 - $27.64
6% of jobs
$27.64 - $32.93
5% of jobs
$32.93 - $38.22
4% of jobs
$42.72 is the 25th percentile. Wages below this are outliers.
$38.22 - $43.51
5% of jobs
$43.51 - $48.80
11% of jobs
$48.80 - $54.09
8% of jobs
$54.09 - $59.38
5% of jobs
The median wage is $59.90 / hr.
$59.38 - $64.66
5% of jobs
$69.39 is the 75th percentile. Wages above this are outliers.
$64.66 - $69.95
23% of jobs
$69.95 - $75.24
23% of jobs
$17
$54
$75
An SDTM Programmer is responsible for converting clinical trial data into standardized Study Data Tabulation Model (SDTM) datasets as per CDISC (Clinical Data Interchange Standards Consortium) guidelines. They ensure that data is structured and formatted correctly for regulatory submissions to agencies like the FDA or EMA. Their work involves writing SAS programs, validating datasets, and collaborating with clinical teams to ensure compliance and accuracy. Strong knowledge of SDTM standards, SAS programming, and clinical trial processes is essential for this role.
SDTM Programmers are primarily responsible for transforming raw clinical trial data into standardized SDTM domains using programming languages like SAS. On a daily basis, you may be involved in mapping study data to SDTM specifications, validating the datasets, resolving discrepancies with data management teams, and documenting your processes for regulatory review. Collaboration with biostatisticians, clinical data managers, and quality assurance teams is also a significant part of the role. These responsibilities ensure that clinical data is accurate, compliant with industry standards, and prepared for analysis and submission to regulatory agencies.
To thrive as an SDTM Programmer, you need a strong background in clinical data management, data standards (especially CDISC SDTM), and programming skills—typically in SAS. Familiarity with SDTM mapping, data validation tools, and relevant regulatory submission platforms or certifications (e.g., SAS Certified Clinical Trials Programmer) is highly valuable. Strong attention to detail, analytical thinking, and effective communication enable collaboration with clinical teams and accurate data interpretation. These skills ensure clinical trial data is accurately standardized, regulatory-compliant, and ready for analysis, which is critical to successful drug development processes.
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8.1
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Nous recherchons un(e) programmeur(se) statistique principal(e) pour fournir un soutien complet de bout en bout en programmation statistique dans le cadre de programmes de developpement clinique. Ce poste exige une expertise technique approfondie, du leadership et une participation active a la realisation des livrables, notamment en ce qui concerne le developpement des jeux de donnees SDTM, ADaM, des tableaux, listings et figures (TLF) ainsi que le soutien aux soumissions reglementaires. Le(la) programmeur(se) statistique principal(e) agira a titre d'expert(e) de contenu, veillera a la qualite des livrables et contribuera a l'elaboration et au maintien des normes et des meilleures pratiques en programmation.
Principales responsabilitesPosition Summary
We are seeking a Principal Statistical Programmer to provide full endtoend statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and handson delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure highquality deliverables, and contribute to programming standards and best practices.
Key Responsibilities
Provide endtoend statistical programming support for clinical studies from study setup through submission
Lead and perform development and validation of:
SDTM datasets
ADaM datasets
Tables, Listings, and Figures (TLFs)
Ensure all deliverables are compliant with CDISC standards and regulatory requirements
Support regulatory submissions (e.g., FDA, EMA), including define.xml, submissionready datasets, and reviewer's guides
Serve as a Principallevel programmer, providing technical leadership and guidance to other programmers as needed
Contribute to and help maintain programming standards, macros, and validation processes
Review and approve programming deliverables to ensure accuracy, consistency, and quality
Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams
Proactively identify risks and propose efficient, compliant solutions within timelines
Required Qualifications
Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field
Extensive experience as a statistical programmer, with demonstrated Principallevel responsibilities
Strong handson experience with:
SDTM and ADaM dataset development
TLF programming
Regulatory submission deliverables
Expert proficiency in base SAS and Advanced SAS with good hands on SAS Macros
Indepth knowledge of CDISC standards, regulatory guidelines, and submission requirements
Proven ability to manage complex studies independently from start to finish
IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de sante pour les secteurs des sciences de la vie et de la sante. IQVIA se consacre a accelerer le developpement et la commercialisation de traitements medicaux innovants pour aider a ameliorer les resultats des patients et la sante de la population dans le monde entier. Pour en savoir plus, visitez https://jobs.iqvia.com
IQVIA est fiere d'etre un employeur souscrivant au principe de l'egalite d'acces a l'emploi. Tous les candidats qualifies seront pris en consideration pour un emploi sans egard a la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identite de genre, l'origine nationale, le handicap, l'age, l'etat matrimonial ou tout autre statut protege par la loi applicable. Des mesures d'adaptation pour les candidats handicapes sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui necessite une mesure d'adaptation, nous vous encourageons a contacter notre equipe d'acquisition de talents au workday_recruiting@iqvia.com, afin qu'IQVIA puisse soutenir votre participation au processus de recrutement.
IQVIA s'engage a faire preuve d'integrite dans son processus de recrutement et applique une politique de tolerance zero en matiere de fraude des candidats. Toutes les informations et toutes les qualifications soumises dans votre candidature doivent etre veridiques et completes. Toute fausse declaration, presentation trompeuse ou omission importante au cours du processus de recrutement entrainera la disqualification immediate de votre candidature, ou la cessation d'emploi si elle est decouverte ulterieurement, conformement aux lois applicables. Nous apprecions votre honnetete et votre professionnalisme.
Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre equipe de recrutement a selectionner ou a evaluer les candidatures, et non pas pour remplacer la prise des decisions par les membres de notre equipe.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: workday_recruiting@iqvia.com, so that IQVIA can support your participation in the recruitment process.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.
La fourchette salariale de base potentielle pour ce poste, annualisee, est de $118,300.00 - $168,300.00. Le salaire de base reel offert peut varier selon plusieurs facteurs, notamment les qualifications liees a l'emploi telles que les connaissances, les competences, la formation et l'experience; l'emplacement; et/ou l'horaire (temps plein ou temps partiel). Selon le poste offert, des regimes d'incitation, des primes et/ou d'autres formes de remuneration peuvent etre proposes, en plus d'une gamme d'avantages sociaux lies a la sante, au bien-etre et/ou d'autres benefices.The potential base pay range for this role, when annualized, is $118,300.00 - $168,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and wellness and/or other benefits.Sourced by ZipRecruiter
At IQVIA, we are passionate about helping customers and partners improve results and patient outcomes. Everything we do contributes to this vision for creating a healthier world. In today’s healthcare environment, it’s not only about how much data, information, and technology you have at your fingertips – it’s what you do with it. IQVIA is focused on making intelligent connections for customers across the entire healthcare ecosystem to help you drive healthcare forward. Whether that means partnering with novel technology companies to boost patient engagement, leveraging AI & machine learning to accelerate results, or using decentralized trials to reach the right patients wherever they are – we are always looking for smarter ways to move you forward.
Health care and social assistance
10,000+ Employees
Durham, NC, US