Support early-phase (Phase I/IIa) clinical studies and biomarker analyses: contribute to study design, sample size calculations, analysis planning, statistical analyses, QC/review, reporting, and sponsor-facing communication.
Who Are You?
A Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support Early Phase clinical studies, in particular Phase IIa (Proof-of-Concept). You are excited and enthusiastic. You never settle for what is, but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsor-dedicated:
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview:
As a Biostatistician, you'll support activities related to early phase / Proof of Concept studies and Biomarker development. You will work closely with the sponsor's experienced Early Phase Biostatisticians and other stakeholders.
As a Biostatistician, your responsibilities will include:
- Providing statistical support to early phase clinical studies (phase I and IIa)
- Working with one or more experienced Biostatisticians, you will support different aspects of clinical trials processes (e.g. study design related contributions, analysis planning, reporting, QC, review of documentation) as required
- Performing statistical analyses using R, SAS or other tools as appropriate, and interpreting statistical results
- Conducting exploratory analyses (e.g. Biomarker) as per the sponsor side's requests
- Ensuring correctness and high quality of own deliverables
- Effectively communicating with the sponsor side, including clarification of requirements, reporting progress, helping others understand the statistical approach used and interpret the results
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- Master’s degree in statistics or a related discipline. Ph.D. is a plus.
- Experience working in the Pharmaceutical or Biotechnology industry.
- Experience in sample size calculation, protocol concept development, protocol development, SAP desired.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is highly desirable.
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- The ability to communicate effectively both internally and externally.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
Cytel Pune, Mahārāshtra, IND Office
Pune, India
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