We are seeking an experienced Statistical Programmer to support clinical data programming activities across global clinical development programs. The role involves developing, validating, and maintaining SAS programs for clinical trial datasets, statistical analysis, Tables, Listings and Figures (TLFs), and regulatory submissions. The successful candidate will collaborate closely with Clinical Data Management, Biostatistics, Clinical Operations, and other cross-functional teams to deliver accurate, high-quality, and timely programming deliverables.

ROLE DETAILS

Location: PAN India

Experience: 5–10 Years

Domain: Pharmaceuticals / Biotechnology / Clinical Research

Role: Statistical Programmer

EDUCATION

Bachelor’s / Master’s degree in Computer Science, Statistics, Mathematics, Data Science, Life Sciences, or a related discipline.

KEY RESPONSIBILITIES

- Develop, validate, and maintain SAS programs for SDTM, ADaM, and TLF datasets.
- Translate study protocols, SAPs, and statistical requirements into efficient programming solutions.
- Perform data extraction, transformation, integration, and validation from multiple clinical data sources.
- Generate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
- Develop validation programs and perform QC of statistical programming deliverables.
- Perform statistical analyses and reporting as per study requirements and SAPs.
- Collaborate with Data Management, Biostatistics, Clinical Operations,



and other cross-functional teams to resolve data and programming issues.
- Ensure compliance with GxP, ALCOA, CDISC, SOPs, and applicable regulatory requirements.
- Maintain complete programming documentation and ensure data integrity.
- Manage multiple projects while meeting timelines and quality expectations.
- Participate in project meetings and proactively communicate project risks and issues.

REQUIRED SKILLS

- Strong experience in Statistical Programming within Pharmaceutical, Biotechnology, or Clinical Research environments.
- Hands-on experience with SDTM, ADaM, and TLF programming.
- Strong knowledge of Base SAS, SAS Macros, and PROC SQL.
- Experience supporting clinical trials and regulatory submissions.
- Good understanding of CDISC standards and clinical trial processes.
- Knowledge of GxP, ALCOA, SDLC, and regulatory requirements.
- SAS Certification will be an added advantage.
- Robust analytical, problem-solving, and communication skills.
- Ability to manage multiple priorities and collaborate effectively with cross-functional teams.

PREFERRED EXPERIENCE

Professionals with experience supporting global clinical studies and regulatory submissions, along with knowledge of pharmaceutical R&D; processes and the ability to work independently in cross-functional environments, are preferred.

Experience in therapeutic areas such as Oncology, Cardiology/Cardiovascular, Diabetes, Immunology, Respiratory, or Rare Diseases will be an added advantage.

INTERESTED CANDIDATES CAN SHARE THEIR UPDATED CVs AT:

📌 Statistical Programmer (Uttar Pradesh)
🏢 Latinum Hr Solutions
📍 Uttar Pradesh