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 productive 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

. Positive 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 (Mumbai)
🏢 Latinum Hr Solutions
📍 Mumbai