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N2S Global Workforce Solutions India Private Limited; India; A distancia; INR 800.000 - 1.200.000; Jornada completa

Descripción de la vacante

N2S Global Workforce Solutions India Private Limited seeks a skilled Statistical Programmer to support clinical research studies through statistical programming, data validation, and the development of high-quality statistical deliverables.

Responsibilities include developing and validating SDTM/ADaM datasets, creating Tables, Listings, and Figures for interim analyses and reports, and preparing Define-XML and Reviewer's Guides. Collaboration with Data Management and Biostatistics is required.

Formación

• Bachelor's degree in Statistics, Computer Science, or related field.
• 1+ year of clinical research experience, including Statistical Programming.
• Strong SAS knowledge.
• Good knowledge of CDISC SDTM/ADaM.
• Exposure to SAP, TLF shells, and programming specs.
• Pinnacle 21 and XML programming is an advantage.
• Familiarity with ICH, GCP, FDA/Health Canada requirements.
• Excellent analytical and organizational skills.

Responsabilidades

• Develop, maintain, and validate SDTM and ADaM datasets for trials.
• Program Tables, Listings, and Figures (TLFs) for analyses and reports.
• Develop and validate annotated Case Report Forms (aCRFs).
• Perform data cleaning and resolve statistical data issues with teams.
• Create dataset specs, Define-XML, and Reviewer's Guides.
• Validate SDTM/ADaM with Pinnacle 21.
• Use SAS macros to improve efficiency and quality.

Conocimientos

SAS programming

SDTM/ADaM

Data validation

CDISC standards

Clinical trial data

GCP/ICH/FDA

Analytical skills

Problem-solving

Educación

Bachelor's degree in Statistics or Computer Science

Herramientas

Pinnacle 21

XML programming

Descripción del empleo

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We are looking for a skilled Statistical Programmer to support clinical research studies through statistical programming, clinical data validation, and the development of high-quality statistical deliverables.

• Develop, maintain, and validate SDTM and ADaM datasets for clinical trials.
• Program Tables, Listings, and Figures (TLFs) for interim analyses, data monitoring, and clinical study reports.
• Develop and validate annotated Case Report Forms (aCRFs).
• Perform data cleaning activities and resolve statistical data issues in collaboration with Data Management and Biostatistics teams.
• Develop and maintain dataset specifications, Define-XML, and Reviewer's Guides.
• Validate SDTM and ADaM datasets using Pinnacle 21.
• Utilize SAS macros and programming standards to improve efficiency and quality.

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• Bachelor's degree in Statistics, Computer Science, or a related field.
• At least 1 year of clinical research experience, including 1 year of Statistical Programming experience in the biotechnology, pharmaceutical, or CRO industry.
• Strong working knowledge of SAS.
• Good knowledge of CDISC standards (SDTM and ADaM).
• Exposure to clinical trial data, Statistical Analysis Plans (SAP), TLF Shells, and programming specifications.
• Knowledge of Pinnacle 21 and XML programming is an advantage.
• Familiarity with ICH guidelines, GCP, and FDA/Health Canada regulatory requirements.
• Excellent analytical, organizational, and problem-solving skills.