Senior Statistician (Biostatistician)

QPS Bioserve India; Hyderabad; On-site; INR 900,000 - 1,800,000; Full time

Job summary

QPS Bioserve India is seeking a skilled Statistician to provide statistical support for clinical trial design, analysis, and reporting. The role involves calculating sample sizes and powers, developing or reviewing SAPs, and interpreting trial data for regulatory submissions.

The candidate will collaborate with Clinical, Data Management, Programming, and Medical teams and contribute to CSR preparation, with emphasis on robustness of statistical methods and regulatory compliance.

Qualifications

• Master's/PhD in Statistics, Biostatistics, or related field.
• Strong knowledge of clinical trial methodology and statistical methods.
• Proficiency in SAS and/or other tools.
• Experience across Phase IIII trials and sample size calculations.
• Strong communication and problem-solving skills.

Responsibilities

• Statistical support for clinical trial design, analysis, and reporting.
• Sample size and power calculations.
• Develop/review SAPs and statistical methods.
• Analyze and interpret clinical trial data and review TLFs.
• Collaborate with Clinical, Data Management, Programming, and Medical teams.
• Support CSRs and regulatory submissions.

Skills

Statistical analysis

Sample size calculations

Phase III trials

Communication skills

Clinical trial methodology

Education

Master's/PhD in Statistics/ Biostatistics

Tools

SAS

Job description

Role & responsibilities:

• Statistical support for clinical trial design, analysis, and reporting.
• Sample size and power calculations.
• Develop/review Statistical Analysis Plans (SAPs) and statistical methods.
• Analyze and interpret clinical trial data and review TLFs.
• Experience with vasoconstriction, PD markers, immunogenicity, safety/efficacy endpoints, and other clinical biomarkers is preferred.
• Collaborate with Clinical, Data Management, Programming, and Medical teams.
• Support CSRs and regulatory submissions.

Requirements:

• Master's/PhD in Statistics, Biostatistics, or related field.
• Strong knowledge of clinical trial methodology and statistical methods.
• Proficiency in SAS and/or other tools.
• Experience across Phase IIII trials and sample size calculations.
• Strong communication and problem-solving skills.