Cytel, India

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development
As Senior Biostatistician, adapt at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. Experience Stats, supporting the activities like performing adhoc or exploratory analyses to support submission or Health Authority Questions. It will be good to have some regulatory work experience, as for example, understanding the regulatory questions and translate them to statistical problems, collaboration effectively, with clinical and regulatory colleagues (with minimal supervision from Project stats).
Summary of Job Responsibilities:

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
interpreting statistical results
preparing clinical study reports, including integrated summaries for submissions
utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay

terms

serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.; being

adaptable and flexible when priorities change
Qualifications and Experience:

Master’s degree in statistics or a related discipline. PhD strongly desired.
5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summa

India

Click Here For More Details