Provides statistical strategy and biostatistical oversight for pharmaceutical clinical trials, including protocols, SAPs, clinical study reports, regulatory documentation, analyses, randomization, and vendor deliverables. Develops innovative statistical methodologies and tools, supports clinical development programs, reviews data management documentation, and contributes to cross-functional standards and infrastructure initiatives.
Who Are You?
As an Associate Director of Biostatistics, you will be dedicated to one of our FSP clients, working as an extension of their staff to support or lead clinical trials for drug development, with the opportunity to leverage your experience and utilize advanced statistical methods in their Statistics group.
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 FSP 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:
Our Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
Your responsibilities will include:
- Support statistical strategy for assigned drug programs, including input to clinical development plans, clinical study concepts and protocols design, SAPs, clinical study reports, regulatory documentation and associated publications.
- Accountable for oversight of the production of biostatistics deliverables (TFLs, including planned, post-hoc, and/or exploratory analyses) as performed by external resources.
- Provide statistical strategy support and input in protocols, CSRs, and scientific presentations and manuscripts.
- Review the randomization procedures and oversight of the production of randomization lists.
- Review study Case Report Forms, data management plan and other data management related documentation to ensure that specific statistical requirements defined in the study protocol are met.
- Oversee outsourced statistical CRO activities and deliverables, ensuring high quality and timely delivery.
- Produce innovative tools and methodologies for statistical analysis through literature review.
- Participate in the development of department strategies and cross functional initiatives on standards, infrastructure, and processes.
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 field, with 7+ years of experience in statistical analysis within the biotech/pharmaceutical industry. PhD preferred.
- Experience with a broad array of statistical approaches and experience in proposing novel approaches to support acceleration of clinical programs. Knowledge in the latest developments in the analytical world including machine learning and artificial intelligence is a plus.
- Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
- Strong statistical programming skills (R, SAS, Python).
- Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications.
- Strong vendor management experience.
- Previous experience in Neuromuscular, Ophthalmology or related TA is preferred.
- Excellent verbal and written communication skills, coupled with strong attention to detail and proactive mindset.
- Demonstrated ability to work independently, take ownership and be accountable for study and program-level statistical activities and deliverables
Cytel Cambridge, Massachusetts, USA Office
Cambridge, MA, United States
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