We are hiring for a leading global organization and seeking experienced
Statistical Programmers
with strong expertise in clinical trial data analysis, programming, and regulatory submissions.
Key Responsibilities
Develop, validate, and maintain statistical programming deliverables for clinical studies.
Create and validate
SDTM
and
ADaM
datasets in compliance with
CDISC
standards.
Generate and validate
Tables, Listings, and Figures (TLFs)
for clinical study reports.
Prepare and support submission deliverables including
Define.xml
, Reviewer Guides, and related documentation.
Develop and maintain
SAS programs, macros, and validation processes
.
Utilize
R programming
for statistical analysis, data visualization, and reporting.
Support regulatory submissions to global health authorities including
FDA
and
EMA
.
Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams.
Ensure adherence to industry standards, SOPs, and regulatory requirements.
Required Skills & Qualifications
5–12 years of experience in Statistical Programming within the Pharmaceutical, Biotechnology, or CRO industry.
Robust hands-on experience with
SAS Programming
and
R Programming
.
In-depth knowledge of
CDISC standards (SDTM & ADaM)
.
Experience in developing and validating
TLFs
,
Define.xml
, and Reviewer Guides.
Valuable understanding of clinical trial processes and regulatory submission requirements.
Experience supporting
FDA
and
EMA
submissions.
Strong analytical, problem-solving, and communication skills.
Preferred Experience
Candidates with experience in any of the following therapeutic areas will be preferred:
Oncology
Immunology
Neuroscience
Why Join?
Prospect to work on global clinical development programs.
Exposure to complex clinical studies and regulatory submissions.
Collaborative and high-performing work environment.
Career growth within a leading