Biostatistician (M. Sc. Biostatistics)

2 weeks ago

Thane, India Bio Scientific Research Laboratiories Pvt Ltd Full time

Must have 2-6 Years of experience in CRO Industry

1. To write/ review statistical SOPs as per need and ensure implementation.

2. Review clinical protocols of bioequivalence/ bioavailability studies related to statistical analysis and providing statistical inputs for the same.

3. Provide sample size based on pilot studies for future pivotal bioequivalence/ bioavailability studies (BA/BA).

4. Generate randomization schedules through the SAS® Version 9.4 software (latest version) for all designs.

5. Analyze Pharmacokinetic data, performing appropriate statistical tests using SAS® Version 9.4 software (latest Version) and preparing appropriate statistical reports for the same.

6. Designs, analyzes, implements, and reports findings on targeted statistical research studies; provides consultation to investigators and researchers on experimental design and statistical research approaches, requirements, and scientific standards to advance medical knowledge and improve research in public health.

7. Works with investigators to formalize analysis plans and reporting specifications; advises as to choose of statistical analysis strategies, reliability of measurements and identifiability of models, and interpretation and presentation of statistical results.

9. Assists in the preparation of clinical trial documents and reports, protocols, investigator brochures, scientific abstracts, peer-reviewed manuscripts, and responses to requests from regulatory agencies, local Institutional Review Board, and other health authorities.

10. Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring.

11. Plans and documents computer data file structure; develops, programs, manages, and maintains complex statistical databases; performs or supervises data entry.

12. Uses a variety of advanced statistical software, methods, and techniques to gather, analyze, and interpret research data to derive useful information for research data; advises and assists in the development of inferences and conclusions, as appropriate.

13. Develops enhancements to statistical software, as appropriate, by programming new techniques; maintains knowledge of current and emerging trends in statistical analysis methodology.

14. Performs miscellaneous job-related duties as assigned.

**Salary**: ₹20,000.00 - ₹30,000.00 per month

Schedule:

- Day shift

Ability to commute/relocate:

- Penkarpada, Thane - 401104, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

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