Senior Statistical Programmer In Pharmacometrics (Pm) Support (Clinical Trials)
Iqvia
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Descrizione del lavoro
Indero is seeking a Senior Statistical Programmer to lead single or multiple clinical trials, developing and validating SDTMs, ADaMs, and TLFs in CDISC-compliant workflows. You will mentor junior programmers, review SAPs and DM documents, and drive process improvements across the biostatistics function.
The role emphasizes SAS and R programming expertise, strong command of CDISC standards, and the ability to work remotely from Argentina with English fluency.
Competenze
- Bachelor's degree in Statistics, Computing Sciences or a related field.
- 5+ years of clinical research experience with 4+ years in Statistical Programming and Lead role.
- Excellent knowledge of SAS; CDISC SDTM/ADaM and ICH guidelines.
Mansioni
- Lead single or multiple clinical trials and develop/validate SDTMs and ADaMs.
- Review DM documents, SAPs, and TLF Shells; ensure data integrity and quality.
- Mentor junior programmers and contribute to programming standards.
- Use Pinnacle 21 for SDTM/ADaM validation and define.XMLs.
- Collaborate with cross-functional teams to improve workflows.
- Stay current with CDISC, ICH guidelines, and industry best practices.
Conoscenze
Formazione
Strumenti
Descrizione del lavoro
Mexico City, Mexico
Santiago, Chile
Buenos Aires, Argentina
Lima, Peru
Quito, Ecuador
São Paulo, Brazil
Bogota, Colombia
Full time
R
Sponsor dedicated - 100% Home based role.
Job Overview
The Principal Stat Programmer plays a critical role in ensuring the accuracy and integrity of statistical programming across various clinical projects. This position demands proficiency in R and SAS programming and familiarity with CDISC standards, particularly ADaM and SDTM models . Key responsibilities include developing and validating complex data sets and outputs, collaborating with cross-functional teams to optimize processes, and providing technical guidance on statistical methodologies and programming best practices. The role also involves mentoring junior programmers and contributing to the continuous improvement of programming workflows and standards, supporting the overall quality deliverables of the statistical programming department.
Essential Functions
- Develops and validates complex datasets and outputs using SAS programming, ensuring compliance with CDISC standards such as ADaM and SDTM models.
- Collaborates with cross-functional teams to optimize statistical programming processes and enhance overall efficiency and accuracy.
- Provides technical guidance and expertise on statistical methodologies to support clinical trial projects and departments.
- Mentors and guides junior programmers, fostering their growth and development.
- Contributes to the continuous improvement of programming workflows and departmental standards.
- Ensures high-quality deliverables from the statistical programming department by adhering to best practices and established protocols.
- Leads initiatives to enhance programming tools and techniques, driving innovation in statistical programming.
- Partners with leadership to align programming objectives with larger organizational goals.
Qualifications
- Bachelor's Degree Statistics, Computer Science or related field.
- 2 + years working with efficacy analysis (Adam datasets & TLF's) and/or 4 + years on ADAM statistical programming on clinical trials.
- Hands-on proficiency in R programming language (mandatory).
- Proficiency in SAS programming language.
- Advanced English (both written and spoken - tested during the interview process).
- Native language is required - LATAM: Spanish or Portuguese.
- Ability to lead/manage others. Capably leads and manages programming teams, ensuring adherence to standards and mentoring junior programmers.
- Demonstrated ability to maintain confidential information, sensitive project data and internal communications.
- Exercises sound judgment and decision-making in selecting statistical methods and programming techniques.
- Effectively manages time and resources to deliver high-quality programming outputs within tight deadlines.
- Executes projects efficiently, demonstrating strong project management skills to coordinate tasks and resources effectively.
- Demonstrates robust technical aptitude with a deep understanding of SAS programming and CDISC standards.
- Analyses and interprets financial data accurately to make informed decisions in statistical programming.
- Applies effective problem-solving skills to overcome programming challenges and optimize workflows.
- Exhibits strong written and verbal communication skills to document programming methodologies and procedures clearly to facilitate collaboration and improve statistical programming processes with cross-functional teams.
- Inspires and motivates programming teams to align their work with organizational goals and quality standards.
Important: submit your CV in English.
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 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
The Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR).The Senior Statistical Programmer will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms (eCRFs), edit checks, etc.), support DM with data cleaning activities, use global SAS macros and participate tointernal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs.
The Senior Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Innovaderm’ standard operating procedures (SOPs) and processes.
More specifically, the Senior Statistical Programmer must:
- Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.
- Act as a Lead Statistical Programmer on multiple single studies.
- Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope.
- Review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells.
- Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician.
- Develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Innovaderm and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT).
- Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Innovaderm and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaMIG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
- Develop/maintain/validate (as applicable) of SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Innovaderm and/or Sponsor' standards and interpretation of CDISC Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
- Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
- Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs.
- Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs.
- Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables.
- Participate to internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables, including but not limited to development/ improvement/validation of standard macros, templates, and programming standards and processes.
- Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements.
May also:
- Mentor more junior Statistical Programmers.
- Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
The Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR).The Senior Statistical Programmer will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms (eCRFs), edit checks, etc.), support DM with data cleaning activities, use global SAS macros and participate tointernal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs.
The Senior Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Innovaderm’ standard operating procedures (SOPs) and processes.
More specifically, the Senior Statistical Programmer must:
- Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.
- Act as a Lead Statistical Programmer on multiple single studies.
- Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope.
- Review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells.
- Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician.
- Develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Innovaderm and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (CT).
- Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs based on protocol, aCRF, SAP, TLF Shells, Innovaderm and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaMIG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
- Develop/maintain/validate (as applicable) of SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Innovaderm and/or Sponsor' standards and interpretation of CDISC Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
- Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
- Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs.
- Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs.
- Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables.
- Participate to internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables, including but not limited to development/ improvement/validation of standard macros, templates, and programming standards and processes.
- Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements.
May also:
- Mentor more junior Statistical Programmers.
- Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Brand name:
Indero
Our company:
At Indero, formely Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
As a Senior Statistical Programmer, you will be eligible for the following perks:
- Permanent full-time position
- Flexible schedule
- Home-based position
- Ongoing learning and development
Work location
The successful candidate for this position is given to work remotely anywhere in Argentina.
About Indero, formely Innovaderm
Indero, formely Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero, formely Innovaderm continues to grow and expand in North Americaand Europe.
Indero, formely Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero, formely Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero, formely Innovaderm only accepts applicants who can legally work in Argentina
- 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.
CRA II
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a **CRA II / Senior CRA** at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.
**What You Will Do:**
You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.
Key responsibilities include:
+ Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
+ Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
+ Collaborating with investigators and site staff to facilitate smooth study conduct.
+ Performing data review and resolution of queries to maintain high-quality clinical data.
+ Contributing to the preparation and review of study documentation, including protocols and clinical study reports
**Your Profile:**
You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills.
Required qualifications and experience:
+ Bachelor's degree in a scientific or healthcare-related field.
+ **Minimum of +1.5 years of experience as a Clinical Research Associate.**
+ In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
+ Strong organizational and communication skills, with attention to detail.
+ Ability to work independently and collaboratively in a fast-paced environment.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to creating a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
Mexico City, Mexico
Buenos Aires, Argentina
Santiago, Chile
Lima, Peru
São Paulo, Brazil
Bogota, Colombia
Full time
R
IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. **The** **Patient Centered Solutions (PCS) team leads the industry in generating data to ensure that the patient voice is incorporated into the development and commercialization of medication and other drug/non-drug interventions.** We focus on understanding and meeting the needs of our clients - mostly life science/pharmaceutical companies - through the application of broad consulting expertise and technical scientific knowledge to design scientifically rigorous research. This research is broad and includes qualitative (e.g. interviews, focus groups), quantitative (e.g. clinical outcome assessments (COAs)/patient-reported outcomes (PROS), preference research) and passive (e.g. digital health technology tools) approaches to understand patient, caregiver and healthcare professional experiences and expectations of disease and treatment.
To meet our client expectations and retain the excellent reputation built up ... (truncated)
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