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 workplace.
- Technical Skills: Expert-level SAS programming skills, with proficiency in SAS/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 [email protected] with the subject line "Application for Biostatistician - Gurugram". #AlzasynoLifeSciences #Biostatistician #Hiring #CROJobs #PharmaJobs #GurugramJobs #ClinicalTrials #CDISC #SDTM #ADaM #SASProgramming #DataScience #JobOpening #Pharmacovigilance

📌 Biostatistician (Gurugram)
🏢 AlzaSyno Life Sciences
📍 Gurugram