Position: Senior Statistical Programmer
Experience: 7+ Years
Location: Hyderabad (On-site)
Employment Type: Full-time
Job Summary
We are looking for an experienced
Senior Statistical Programmer with 7+ years of expertise in clinical trial data analysis and programming within the pharmaceutical, CRO, or biotech industry. The ideal candidate should have strong hands-on experience in
SAS programming, CDISC standards (SDTM/ADaM), TLF generation, and regulatory submissions.
Key Responsibilities
- Develop, validate, and maintain SAS programs for analysis datasets, tables, listings, and figures (TLFs).
- Create and review SDTM and ADaM datasets as per CDISC standards.
- Support clinical study reporting, interim analyses, and final study deliverables.
- Perform quality control (QC) and validation of programming outputs.
- Collaborate with Biostatistics, Data Management, Clinical Operations, and Medical Writing teams.
- Prepare datasets and documentation for regulatory submissions (FDA, EMA, PMDA).
- Review Statistical Analysis Plans (SAP), CRFs, and protocols.
- Lead programming activities for multiple studies/projects.
- Mentor junior programmers and provide technical guidance.
- Ensure compliance with SOPs, GCP, and company standards.
Required Skills & Qualifications
- Bachelor's/Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.
- 7+ years of experience in Statistical Programming in clinical research.
- Strong expertise in Base SAS, SAS Macro, SQL, and SAS/STAT.
- Hands-on experience with CDISC SDTM, ADaM, Define.xml.
- Experience in generating TLFs and submission-ready datasets.
- Good understanding of clinical trial processes and regulatory requirements.
- Knowledge of tools like R, Python, Pinnacle 21 is an added advantage.
- Excellent communication and leadership skills.
Preferred Experience
- Experience working in Phase I-IV clinical trials.
- Oncology, Vaccines, or Rare Disease therapeutic area experience preferred.
- Exposure to global client/stakeholder management.
Key Competencies
- Analytical thinking
- Problem-solving
- Attention to detail
- Team collaboration
- Leadership & mentoring
Skills: sas,python,sql,cdisc standards,r,statistical programming
