Biostatistician II FSP (Early Phase)
Cytel · Pune · onsite · Posted 48d ago
Undisclosed3–7 yrsfulltimeSourced from
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About this role
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, youll be at the heart of our clients 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, youll support activities related to early phase / Proof of Concept studies and Biomarker development. You will work closely with the sponsors experienced Early Phase Biostatisticians and other stakeholders. You may lead some study or publication activities too depending on the situation.
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.
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 sides 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
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
SAPclinical trialssideSAS ProgrammingProgrammingr programmingclinical developmentSASProtocol developmentPharma
About Cytel
Cytel
Cambridge
GB
₹11.9L PA avg
Avg at Cytel
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