Purpose of the role:

We are seeking an experienced Biostatistician to support our Clinical Affairs team in Europe. This position will be based at Mumbai. The role will provide statistical leadership for clinical investigations, post-market clinical follow-up (PMCF) studies, registries, and other clinical evidence generation activities supporting Occlutech's structural heart device portfolio.

The successful candidate will be responsible for statistical planning, analysis, interpretation, and reporting of clinical data using SAS while ensuring compliance with applicable regulatory and quality requirements. This position will work closely with Clinical Affairs, Medical Affairs, Regulatory Affairs, Data Management, and other global cross-functional stakeholders

Roles & Responsibilities:

1) Clinical Study Design & Planning

- Support the design and statistical planning of clinical investigations, PMCF studies, registries, and observational studies.
- Develop and review Statistical Analysis Plans (SAPs).
- Perform sample size calculations and power analyses.
- Provide statistical input into study protocols and clinical study documentation.
- Ensure statistical methodologies align with applicable regulatory requirements and industry standards.

2) Statistical Programming & Data Analysis

- Perform statistical analyses using SAS Programming.
- Develop and validate statistical programs and outputs.
- Generate tables, listings, figures, and statistical summaries.
- Conduct descriptive, inferential, survival, regression, and multivariate analyses as appropriate.
- Analyze safety, effectiveness, and performance endpoints.




- Support interpretation of clinical data and evidence generation activities.

3) Clinical & Regulatory Support

- Provide statistical support for Clinical Evaluation Reports (CERs), Clinical Investigation Reports (CIRs), PMCF Evaluation Reports, and regulatory submissions.
- Support interactions with regulatory authorities and Notified Bodies.
- Contribute to risk-benefit evaluations and clinical evidence assessments.
- Assist in preparation of regulatory and clinical documentation.

4)Scientific Communication

- Prepare statistical reports and analysis summaries.
- Support publication of clinical study results in peer-reviewed journals and scientific conferences.
- Present statistical findings to internal and external stakeholders.
- Collaborate with global Clinical, Medical, and Regulatory teams.

5) Quality & Compliance

- Ensure compliance with EU MDR, ISO 14155, Good Clinical Practice (GCP), and internal quality procedures.
- Maintain audit-ready statistical documentation and records.

1. Participate in inspections and audits as required..

Skills & Qualifications:

Mandatory

- Strong expertise in SAS Programming.
- Sound knowledge of biostatistical methods and clinical trial design.
- Experience in development and review of Statistical Analysis Plans (SAPs).
- Solid clinical data analysis and interpretation capability.
- Knowledge of clinical research methodologies and regulatory requirements.

Preferred

- Knowledge of R, SPSS, or STATA.
- Familiarity with EU MDR, ISO 14155, and GCP requirements.

Experience with PMCF, PMS, CER, and Clinical Investigation activities

📌 Biostatistician - EU Region (Clinical Affairs) (Mumbai)
🏢 Alkem MedTech
📍 Mumbai