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Biostatistician

3 months ago

Pune, Maharashtra, India Cytel, India Full time

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 a Biostatistician, expected to support 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 mínimal 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.
Exposure to efficacy and exploratory analysis is preferred.

  • 3+ 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 summaries for submissions.
  • Knowledge and implementation of advanced statistical methods.
  • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
  • Strong knowledge of ICH guidelines.
  • Solid understanding & implementation of CDISC requirement for regulatory submissions.
  • Adept in ADaM specifications generation and QC of datasets.
  • Submissions experience
  • Experience working with crossfunctional teams, a Study Management Team (SMT) or similar teams for different clients.
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms.
  • Team player; willingness to go the extra distance to get results, meet deadlines, etc.
  • Ability to be flexible when priorities change and deal with ambiguity
Cytel Inc. is an Equal Employment / Affirmative Action Employer.

Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.