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9 Cytel Statistical Software & Services Jobs
Biostatistician II FSP
2-5 years
₹ 7 - 15L/yr (AmbitionBox estimate)
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Biostatistician II FSP
Cytel Statistical Software & Services
posted 6hr 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.
- 5+ 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.
- Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
- Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
- Participate in the development of CRFs, edit check specifications, and data validation plans
- Provide review and/or author data transfer specifications for external vendor data
- Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
- Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices
Employment Type: Full Time, Permanent
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What people at Cytel Statistical Software & Services are saying
Rating based on 2 Biostatistician
reviews
Anonymous · Data Science & Analytics
in Pune
Work culture, respect, growth and work life balance
- Salary - Good
Opportunities to go abroad
Biostatistician salary at Cytel Statistical Software & Services
What Cytel Statistical Software & Services employees are saying about work life
Cytel Statistical Software & Services Benefits
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