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 effective 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. Strong 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 (India)
🏢 Latinum Hr Solutions
📍 India