Job Title : Biostatistician

Functional Area : Clinical Trials

Reports To : Senior Manager Clinical Trials

Division : Clinical Trails Key Accountabilities

- Develop, author, review and finalize Statistical Analysis Plans (SAPs) and TLF mock shells in alignment with protocol objectives and regulatory requirements.
- Perform end-to-end statistical analyses using SAS, including ANOVA, ANCOVA, MMRM, logistic regression, survival analysis and Cox proportional hazards models.
- Generate, validate and QC Tables, Listings and Figures (TLFs) in compliance with CDISC SDTM/ADaM standards and study-specific SAP specifications.
- Conduct survival analyses such as Kaplan-Meier estimation, log-rank testing and time-to-event modeling for clinical studies.
- Apply missing data methods such as multiple imputation using PROC MI and MIANALYZE, following ICH E9(R1) estimand principles.
- Support preparation of Clinical Study Reports (CSRs), statistical sections for regulatory dossiers, and integrated submissions such as ISS/ISE.
- Review CRFs, annotated datasets, source data and perform QC checks against SDTM/ADaM specifications.
- Collaborate with Clinical Operations, Data Management, Programming, Medical Writing and Regulatory Affairs teams to ensure timely and audit-ready deliverables.
- Contribute to analysis of non-inferiority studies, propensity score matched studies and other advanced statistical methods as required.




- Ensure compliance with ICH-GCP, ICH E9 and applicable USFDA and global regulatory guidelines.

Key Measures

- Strong proficiency in SAS programming, including Base SAS, PROC SQL, PROC REPORT, ODS and procedures such as GLM, MIXED, LOGISTIC, PHREG, LIFETEST, MI and MIANALYZE.
- Working knowledge of R for statistical graphics, survival analysis and data manipulation.
- Strong understanding of CDISC standards, including SDTM and ADaM and experience in TLF generation and validation.
- Experience in SAP development, mock shell creation, CSR support and regulatory submission deliverables.
- Knowledge of survival analysis, non-inferiority testing, regression modeling and handling missing data.
- Familiarity with ICH-GCP, ICH E9, USFDA guidelines and clinical trial lifecycle across Phase IIV studies.
- Ability to work in rapid-paced, cross-functional, global study environments with strong communication and documentation skills.
- Experience in therapeutic areas such as cardiology or orthopedics will be an advantage.

Eligibility criteria

- Masters degree in Statistics, Biostatistics, Mathematics or a closely related quantitative discipline.
- 2 to 4 years of relevant experience in biostatistics, statistical programming or clinical data analysis.
- Hands-on experience in clinical trials, preferably across Phase I to Phase IV studies.

📌 Bio Statistician (Gujarat)
🏢 Sahajanand Medical Technologies
📍 Gujarat