Biostatistician

Alzasyno Life Sciences Pvt Ltd is #hiring for a Biostatistician to join our team in Gurugram! 🌟
We are looking for a skilled professional with 5–8 years of experience in the CRO/Pharma industry to lead statistical activities for our clinical trials. If you have a strong foundation in clinical trial methodology and regulatory standards, we want to hear from you!
Key Responsibilities:
Lead the statistical design and analysis for clinical trials, including the development and review of Statistical Analysis Plans (SAPs) and protocols.
Perform sample size calculations, develop randomization schemes, and ensure scientifically sound statistical methodologies.
Oversee the creation and validation of SDTM and ADaM datasets, ensuring full compliance with CDISC standards.
Generate, review, and quality control Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
Manage and support internal and external audits, ensuring all statistical deliverables adhere to ICH-GCP and regulatory guidelines.
Provide statistical input for regulatory submissions (e.g., IND, NDA) and support responses to health authority queries.
Collaborate with cross-functional teams including Clinical, Data Management, and Medical teams to ensure seamless project execution.
Ideal Candidate Profile:
Experience: 5–8 years in a CRO or Pharmaceutical environment.
Technical Skills: Expert-level SAS programming skills, with proficiency in R or Python as a plus.
Regulatory Knowledge: Strong understanding of CDISC (SDTM/ADaM), ICH-GCP, and global regulatory requirements (FDA, EMA).
Soft Skills: Excellent communication, leadership, and problem-solving abilities with a high attention to detail.
If you are passionate about leveraging data to drive drug development, we would love to connect! Please send your updated CV to hr@alzasyno.com with the subject line "Application for Biostatistician - Gurugram".
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