Senior Statistical Programmer

3 semanas atrás

Buenos Aires Espírito Santo Brazil Indero (formerly Innovaderm) Tempo inteiro
Senior Statistical Programmer (Argentina)
  • CRO - Biometrics
  • Argentina
  • Professional
  • Permanent
Description

The Senior Statistical Programmer will lead multiple clinical trials and be responsible for developing, maintaining, and validating annotated Case Report Forms (aCRFs), specifications, and statistical programming of SDTM datasets, ADaM datasets, Tables, Listings, and Figures (TLFs), and submission packages. These deliverables support data review meetings, interim analyses, and clinical study reports. The role also involves reviewing and providing input into Statistical Analysis Plans (SAPs), TLF Shells, and Data Management (DM) documents, supporting data cleaning activities, utilizing global SAS macros, and validating SDTMs, ADaMs, and define.XMLs with Pinnacle 21.

The Senior Statistical Programmer will collaborate within Biostatistical study teams to produce high-quality deliverables within timelines and budgets, following ICH guidelines, industry standards, regulatory requirements, and company SOPs.

Specific responsibilities include:

  • Adhering to company values and SOPs, completing trainings on time.
  • Acting as a Lead Statistical Programmer on studies.
  • Reviewing programming scope, budget, and out-of-scope tasks.
  • Reviewing DM documents, SAPs, and TLF Shells.
  • Supporting data cleaning activities.
  • Developing and validating aCRFs, SDTMs, ADaMs, and TLFs according to standards and guidelines.
  • Creating and validating define.XML files and reviewer guides.
  • Using Pinnacle 21 for validation and addressing findings.
  • Utilizing global SAS macros for efficiency.
  • Acting as unblinded primary or QC programmer for randomization plans, IDMCs, and IAs.
  • Contributing to initiatives to improve efficiency and quality.
  • Staying updated on industry and CDISC standards and regulations.

May also involve mentoring junior programmers.

Requirements

Education

Experience

  • At least 7 years of clinical research experience in biotech, pharma, or CRO, including 5 years in statistical programming and 2 years as a Lead Programmer.

Knowledge and Skills

  • Strong experience with clinical trial data, SAPs, TLFs, and specifications.
  • Proficiency in SAS; SAS certification preferred.
  • Knowledge of XML programming is a plus.
  • Familiarity with CDISC standards; CDISC certification preferred.
  • Deep understanding of drug development, ICH guidelines, regulations, and electronic data submissions.
  • Highly organized, detail-oriented, with good project management skills.
  • Ability to work independently and in teams, managing multiple priorities.
  • Excellent communication skills in English.
Our company

The work environment

At Indero, you'll work with talented colleagues in a culture of collaboration, innovation, reliability, and responsiveness. We offer a stimulating environment and growth opportunities.

Perks include:

  • Permanent full-time position
  • Benefits package
  • Ongoing learning and development

Work location

This is a home-based position in Argentina.

About Indero

Indero is a global leader in dermatology and rheumatology clinical research, with over two decades of experience and a broad international footprint. We provide comprehensive services from protocol design to trial monitoring and biometrics, serving biotech and pharma clients worldwide.

Indero is committed to diversity and equal opportunity. We provide accommodations during recruitment upon request and only accept applicants authorized to work in Argentina.

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