Company: Cytel Software Corporation
Location: San Jose
Posted on: August 5, 2022
Join us in playing an important part in helping our clients
drive healthcare forward and ultimately improve human health
Cytel provides unrivalled biostatistics and operations research to
improve drug development success rates, crucial for human welfare.
Focused on using innovative applications of statistical science and
adaptive clinical trial design, Cytel is at the cutting edge of
technology and human ingenuity, driving healthcare forward.
We are hiring a remote Principal/Senior Biostatistician to work
directly with a pharma company s internal team leading project
efforts and providing statistics knowledge . This position reports
to the Associate Director of Biostatistics in FSP Services business
unit in Cytel.
The (Principal/) Senior Biostatistician position is part of the
Research and Development team to develop and provide scientifically
sound analyses that answer questions to support product
development. The level of this position will be determined based on
the amount of the candidate s industry experience and statistical
- MS or PhD in Statistics, Mathematics, or related field with 3+
- Excellent writing, communication, and project management
- Proficient SAS programming skills, solid understanding of CDISC
SDTM and ADAM models and standards.
- Support clinical development biostatistics with core
deliverables (SAP, CSR TLFs, etc.) and exploratory analyses
necessary for submissions and regulatory queries.
- Experience in Neuroscience, Oncology, Early Phase, or Medical
- Experience with sample size estimation (e.g., in SAS, R,
N-Query, or simulation).
- Specification reviews, Reviewer s Guide
- An additional qualification of Principal Biostatistician: the
Principal Biostatistician will bring additional experience (5+
years) and is expected to mentor/manage less experienced staff.
Skills and Knowledge Requirements
- Experience in a matrix team environment
- Excellent written and oral communication skills and
demonstrated problem-solving abilities
- Ability to work proactively while handling multiple
deliverables and short timelines
- Computer proficiency in SAS, Microsoft Word, Excel, and
- Must be able to prioritize and multi-task, work effectively
with little or no direction, and build collaborative relationships
with management, partners, and peers from diverse backgrounds.
- Ability to work across multiple projects
- Demonstrated working knowledge of GCP, ICH guidelines and FDA
- Understanding of study phases and general knowledge of how they
apply to biostatics and statistical programming
- Demonstrated ability to work independently and in a team
- Ability to create and maintain of study-specific data
- Ability to interface cross-functionally with Data
- Ability to assist with the training of new study team
Keywords: Cytel Software Corporation, San Jose , Principal Biostatistician, Other , San Jose, California
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