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Biostatistician I FSP
3-4 years
₹ 9.4 - 10.2L/yr (AmbitionBox estimate)
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Biostatistician I FSP
Cytel Statistical Software & Services
posted 10hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Master s degree in statistics or a related discipline. Ph.D. strongly desired.
- 3+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
- Experience working for a CRO is strongly desired.
- Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- Adept in ADaM specifications generation and QC of datasets.
- The ability to build strong external & internal relationships and motivate a regional or global team.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
- Providing statistical support to clinical studies
- Participating in the development of study protocols, including participation in study design discussions and sample size calculations
- Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications
- Performing statistical analyses and interpreting statistical results
- Preparing clinical study reports, including integrated summaries for submissions
- Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
Employment Type: Full Time, Permanent
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Anonymous · Biostatistics
in Pune
Work culture, respect, growth and work life balance
Opportunities to go abroad
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