Biostatistician 3+yrs immediate joiners(Mumbai)

• Role : Biostatistician
• Location: Navi Mumbai, India (Office Based)

Required Qualifications & Experience -

Master's or PhD in Biostatistics, Statistics, or related field.

- 3–7 years of experience in clinical trials within CRO or pharmaceutical industry.

- Proficiency in SAS and/or R programming.

- Strong understanding of clinical trial design and statistical methodologies.

- Experience with CDISC standards (SDTM/ADaM) preferred.

- Good knowledge of regulatory guidelines (FDA, EMA, ICH).

- Strong analytical and problem-solving skills

Key Responsibilities - Provide statistical input into study protocols, study design, and sample size calculations.

- Develop Statistical Analysis Plans (SAPs) in accordance with study protocols.

- Perform statistical analysis using SAS/R and generate tables, listings, and figures (TLFs).

- Support interim and final analyses for clinical trials.

- Collaborate with Data Management and Clinical teams to ensure data quality and integrity.

- Review CRFs, datasets, and data specifications.

- Support regulatory submissions (IND, NDA, BLA) with statistical outputs.

- Participate in client meetings and provide statistical insights.

- Ensure compliance with ICH-GCP, regulatory guidelines