Lead statistical activities for vaccine clinical development: author and review SAPs, analyze SDTM/ADaM data, produce TLFs, support regulatory submissions, and coordinate with sponsor teams.
Who Are You?
An experienced Biostatistician with clinical trial setting experience. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. 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:
We are seeking a highly motivated Biostatistician to support Vaccines projects across the drug development lifecycle. The ideal candidate will have a strong foundation in statistical methodologies and programming and will play a critical role in analyzing complex manufacturing data to ensure product quality, consistency, and regulatory compliance.
As a Principal Biostatistician, your responsibilities will include:
- Provide statistical leadership and statistical expertise into clinical development plans, concept sheets and protocols for clinical development projects, represent Cytel and the statistical team on the Product Development Teams of sponsors.
- Work with client statistical team, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across clinical trials of each assigned project.
- Provide statistical input into study protocols, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
- Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.
- Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
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:
Required Qualifications:
- MS or PhD in statistics, biostatistics, or related fields with relevant industry working experience.
- 2+ years experience working in clinical trial setting.
- Proficient with SAS. R is nice to have.
- Have experience in authoring and reviewing SAP/TLF shells.
- Familiar with CDISC standards. Have experience in reviewing SDTM/ADaM specs.
- Have experience in programming and validating SDTM/ADaM/TLFs.
- Experience in submission is a plus
- Experience with Vaccines studies is preferred.
- Strong communication, both verbal and written.
Cytel Pune, Mahārāshtra, IND Office
Pune, India
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