Clinical Data Statistical Analyst
Job Summary:
CareMother by Doto Health is seeking a detail-oriented and motivated Clinical Data Statistical Analyst to join our team in Pune. As a Clinical Data Statistical Analyst, you will play a vital role in the statistical analysis of clinical trial data, ensuring the integrity and accuracy of our research. This is a full-time, on-site position offering a unique opportunity to contribute to a growing healthcare analytics company and make a real difference in the lives of patients.
Responsibilities:
- Conduct statistical analyses for clinical trials, including descriptive statistics, inferential testing, survival analysis, and regression modeling.
- Develop and validate Statistical Analysis Plans (SAPs) in accordance with study protocols and ICH–GCP guidelines.
- Generate Tables, Listings, and Figures (TLFs) and create ad-hoc statistical reports using R/SAS/Python.
- Collaborate with clinical data managers, programmers, and biostatisticians to ensure high-quality datasets.
- Support sample size calculations, power analysis, and interim data reviews.
- Interpret statistical outputs for Clinical Study Reports (CSRs), publications, and presentations.
- Maintain comprehensive documentation for audit readiness and reproducibility.
- Stay current with modern statistical methods, including adaptive trial designs and ML-based biostatistics.
Requirements:
Education:
- Master’s degree in Biostatistics, Statistics, Public Health, or a related field.
Experience:
- 1–2 years of hands-on experience in clinical trial data analysis or pharmaceutical/biotech analytics.
- Experience in analyzing diagnostic assay data is preferred.
Technical Skills:
- Proficiency in R, SAS, Python (pandas, statsmodels), or SPSS.
- Experience with EDC systems like Medidata Rave / Oracle Clinical.
- Familiarity with CDISC standards (SDTM, ADaM).
- Solid understanding of ANOVA, logistic regression, mixed-effects models, and hypothesis testing.
Soft Skills:
- Excellent analytical and communication skills.
- Ability to work independently and collaboratively in cross-functional teams.
- Strong ethical mindset for handling sensitive clinical data.
Preferred Qualifications:
- SAS Certification (Base/Advanced).
- Experience with regulatory submissions (IND/NDA).
- Exposure to patient counseling data in diagnostic studies.
- Publications in clinical statistics.
Benefits:
- Competitive salary (up to ₹30,000 per month).
- Opportunity to work on real-world clinical datasets.
- Exposure to regulatory-driven statistical workflows.
- Collaborative work culture in a fast-growing healthcare analytics company.
How to Apply:
If you are a passionate and dedicated professional with a strong background in biostatistics and a desire to contribute to cutting-edge clinical research, we encourage you to apply. Please submit your resume and cover letter detailing your qualifications and experience. We look forward to hearing from you!