Lead and deliver statistical support for Phase II-III clinical trials embedded with a sponsor: design input, SAP/sample size, interim/final analyses, oversight of programmers/statisticians, regulatory submissions, and collaborate cross-functionally to ensure compliant, high-quality statistical deliverables. Apply advanced statistical methods and ML/DL for analytics and process automation.
Who Are You?
As an Associate Director of Biostatistics, you will be dedicated to one of our major Pharma 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 Global Portfolio 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 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:
Our team provides 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.
As a AD Biostatistician, your responsibilities will include:
- Lead statistical support for assigned clinical studies, taking ownership of key activities such as dry runs, interim analyses, DMC interactions, and final analysis and CSR delivery
- Serve as the primary statistical contact for cross-functional teams, ensuring timely delivery and approval of high-quality, compliant statistical deliverables
- Build and maintain strong collaboration with sponsor teams, acting independently while ensuring alignment with sponsor expectations and standards
- Collaborate closely with clinical, data management, programming, and other stakeholders to develop and finalize study outputs in line with regulatory and protocol requirements
- Provide statistical input into study design and key documents (protocol, CRFs, DMP, SAP), ensuring alignment with study objectives and sponsor expectations
- Support development and review of analysis datasets and TLFs, working closely with programming teams to ensure quality and consistency of outputs
- Contribute to clinical study reports and regulatory submissions, and support interactions with regulatory authorities as needed
- Coordinate statistical activities across studies within the assigned project, ensuring alignment of objectives, consistency of approach, and on-time delivery
- Guide and oversee statisticians and programmers (as applicable) to ensure quality and consistency of statistical strategy, deliverables, 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 related quantitative discipline; PhD preferred
- ~7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry
- Solid recent experience (≥3 years) in Phase II–III studies, including SAP development, sample size calculation, and TLF review
- Strong knowledge of clinical trial design, including adaptive designs, statistical methodologies, and data interpretation
- Good understanding of the drug development process and cross-functional interfaces
- Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions
- Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams
- Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables
- Experience supporting end-to-end trial delivery (from protocol input through CSR contributions)
- Ability to interact effectively with cross-functional stakeholders and external partners
- Strong focus on timely, high-quality and compliant deliverables with clear accountability for outcome
- Ability to proactively identify risks and ensure appropriate mitigation and follow-up
- Effective communication skills (clear, concise, and professional)
- Strong organizational and project management skills
- Collaborative, flexible, and solution-oriented mindset
- High attention to detail and quality
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