Senior Statistical Programmer (Argentina)

Innovaderm Research

7+ years

preferred by company

Argentina

10 Nov. 24, 2024

Job Description

Job Type: Full Time Education: Bachelor’ degree in Statistics, Computing Sciences or a related field Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Statistical Programmer - Innovaderm (Remote, Argentina)

Overview
Innovaderm is seeking a Senior Statistical Programmer to lead and oversee multiple clinical trials. The role will be responsible for developing, maintaining, and validating annotated Case Report Forms (aCRFs), Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and Tables, Listings, and Figures (TLFs). The Senior Statistical Programmer will work with cross-functional teams to ensure high-quality deliverables in compliance with International Council for Harmonization (ICH) guidelines, CDISC standards, regulatory requirements, and Innovaderm’s standard operating procedures (SOPs).

Responsibilities

Statistical Programming & Data Management

Lead statistical programming efforts for multiple clinical trials, ensuring the development of high-quality deliverables within agreed timelines and budgets.
Review and provide input into various data management documents such as eCRF, edit checks, Statistical Analysis Plans (SAPs), and TLF Shells.
Support Data Management (DM) teams in data cleaning activities, programming and addressing statistical data issues in collaboration with other Statistical Programmers and Biostatisticians.
Develop, maintain, and validate aCRFs according to the protocol, eCRF, and Innovaderm/Sponsor standards, ensuring compliance with CDISC SDTM Implementation Guidelines and Controlled Terminology (CT).
Develop and validate SDTM, ADaM datasets, and TLF specifications in line with protocol, SAP, TLF Shells, and CDISC standards.
Develop and validate SDTM and ADaM define.XML/.PDF, Reviewer’s Guides, and other documentation.
Use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs, ensuring compliance with industry standards.
Utilize global SAS macros to enhance programming efficiency for SDTM, ADaM datasets, and TLFs.

Leadership & Process Improvement

Act as Unblinded Primary or QC Statistical Programmer for randomization plans, interim analyses (IAs), and Data Monitoring Committee (DMC) data reviews.
Contribute to internal initiatives aimed at improving efficiency and quality in statistical programming processes, including the development of standard macros, templates, and programming standards.
Mentor junior Statistical Programmers and guide them on best practices.
Stay up-to-date with the latest industry trends, CDISC standards, ICH guidelines, and regulatory requirements.

Collaboration & Communication

Collaborate effectively with Biostatistics and cross-functional teams to ensure high-quality deliverables.
Communicate with internal and external stakeholders to ensure alignment on study timelines, requirements, and deliverables.
Participate in company initiatives to increase efficiency and quality in statistical programming activities.

Requirements

Education

Bachelor’s degree in Statistics, Computing Sciences, or a related field; Master’s degree preferred.

Experience

At least 7 years of clinical research experience in biotechnology, pharmaceutical, or Contract Research Organization (CRO) industries.
Minimum of 5 years of experience in Statistical Programming, with at least 2 years in a lead role.

Knowledge & Skills

Strong knowledge of clinical trial data, SAPs, TLF Shells, and specifications.
Extensive experience with SAS programming (SAS certification is an asset).
Knowledge of XML programming is a plus.
Familiarity with CDISC standards and guidelines (CDISC certification is a plus).
In-depth understanding of the drug development process, ICH guidelines (including E6, E9, E9(R1)), and relevant regulatory requirements (Health Canada, FDA).
Strong organizational skills and attention to detail, with the ability to manage multiple projects in a fast-paced environment.
Excellent verbal and written communication skills in English.
Ability to work independently and as part of a team.

Why Innovaderm?

Work Environment
At Innovaderm, you will work with talented and motivated colleagues. We value collaboration, innovation, reliability, and responsiveness. We offer a stimulating environment with ample opportunities for growth and development.

Benefits

Flexible work schedule.
Home-based position.
Ongoing learning and development.

About Innovaderm

Innovaderm is a leading contract research organization (CRO) specializing in dermatology. Established in 2000, the company has built a strong reputation for delivering high-quality research and services that exceed client expectations. Headquartered in Montreal, Innovaderm continues to expand its presence in North America and Europe.

Equity Commitment
Innovaderm is an equal opportunity employer and is committed to providing accommodations during the recruitment process to applicants with disabilities, upon request.

Eligibility
This role is open to applicants who are legally authorized to work in Argentina.

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