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.
- Strong 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?
- Opportunity 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