Statistical Programmer | Remote

N2S Global Workforce Solutions LLC; Manila; Remote; PHP 400,000 - 600,000; Full time

Job summary

N2S Global Workforce Solutions LLC is seeking a Statistical Programmer to support clinical studies remotely. The role emphasizes statistical programming, data validation, and delivering high-quality statistical deliverables.

You will develop SDTM/ADaM datasets, generate TLFs for analyses, and develop annotated CRFs, collaborating with Data Management and Biostatistics. Strong SAS and CDISC knowledge are essential.

Qualifications

• Bachelor's degree in Statistics, CS, or related field.
• Minimum 1 year of clinical research experience with statistical programming.
• Strong working knowledge of SAS.
• Familiar with CDISC SDTM/ADaM standards.
• Experience with Pinnacle 21 and XML programming is a plus.
• Knowledge of ICH/GCP/FDA regulatory requirements.

Responsibilities

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

Skills

Bachelor's degree

Clinical research

SAS

CDISC SDTM/ADaM

Pinnacle 21

ICH/GCP/FDA

Analytical skills

Problem solving

Education

Bachelor's degree in Statistics, CS, or related

Tools

SAS

Job description

WE’RE HIRING: STATISTICAL PROGRAMMER | REMOTE

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.

KEY RESPONSIBILITIES

• 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.

KEY QUALIFICATIONS

• 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.