Lead statistical activities for Phase II–III clinical trials from protocol design through reporting. Responsibilities include SAP development, sample size calculations, statistical analysis, TLF review, database lock and submission support, regulatory responses, vendor oversight, and cross-functional collaboration. Use SAS and/or R for analyses, modeling, simulation, exploratory work, and quality control. Coordinate statistical activities across studies and apply adaptive, group sequential, count-data, machine learning, and deep learning methods.
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 Therapeutic 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 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:
- Lead statistical activities for assigned Clinical Trials (mainly Phases 3) independently from protocol design to reporting of results.
- Represent Statistics function on cross-functional trial teams and collaborate effectively with all cross-functional stakeholders.
- Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
- Contribute to or lead other activities from a statistical perspective as appropriate, including database lock and submission activities, safety reporting, adhoc requests and respond to regulatory questions.
- Collaborate closely with clinical, data management, programming, and other stakeholders to develop and finalize study outputs in line with regulatory and protocol requirements
- Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
- Coordinate statistical activities across studies within the assigned project, ensuring alignment of objectives, consistency of approach, and on-time delivery
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 adaptive design, group sequential and statistical methods of count data
- Prior experience on Hematology studies preferred
- Good understanding of the drug development process and cross-functional interfaces and experience supporting end-to-end trial delivery (from protocol input through CSR contributions)
- 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
- Excellent and effective communication skills (clear, concise, and professional) and ability to interact effectively with cross-functional stakeholders and external partners
- Strong organizational and project management skills
- Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables
Similar Jobs
Information Technology • Internet of Things • Mobile • On-Demand • Software
Leads enterprise new-business sales strategy, revenue growth, and acquisition of strategic customers. Builds and develops enterprise sales leaders and hunters, cultivates C-level relationships, manages major technology pursuits, and strengthens cloud and alliance partnerships. Owns forecasting, pipeline governance, sales productivity, organizational performance, and succession planning while driving go-to-market strategy across cloud, managed services, cybersecurity, infrastructure, AI, and digital transformation markets.
Top Skills:
Artificial IntelligenceAWSBroadcom VmwareChallengerCommand Of The MessageCrm PlatformsCybersecurityForecasting ToolsGCPMeddpiccAzureMiller HeimanSales Analytics
Fintech • Machine Learning • Payments • Software • Financial Services
Own referral and lifecycle marketing strategy, product-led growth, user engagement, lifetime value, and profitable growth. Lead offer economics, analytics, P&L ownership, product and pricing strategy, direct-to-consumer marketing, and customer experience development. Recruit and manage a high-performing growth team while partnering across Product, IT, Sales, Operations, and Finance. Drive business requirements, credit-risk analysis, project execution, strategic decisions, and performance improvement.
Top Skills:
AIAi AgentsCursorGithub Copilot
Fintech • Machine Learning • Payments • Software • Financial Services
Lead greenfield product development for Capital One Shopping’s Categories team. Build scalable distributed microservices and backend architectures using modern cloud-native technologies, while contributing across full-stack systems, big data pipelines, and analytics platforms. Partner with product managers to define technical strategy, architect consumer experiences, review code, and mentor engineers. Work with JavaScript, TypeScript, SQL, Python, Go, AWS, databases, Docker, and Kubernetes.
Top Skills:
AWSDistributed Nosql DatabasesDockerGoGCPJavaScriptKubernetesMicroservicesAzureOpen Source RdbmsPythonSQLTypescript
What you need to know about the Seattle Tech Scene
Home to tech titans like Microsoft and Amazon, Seattle punches far above its weight in innovation. But its surrounding mountains, sprinkled with world-famous hiking trails and climbing routes, make the city a destination for outdoorsy types as well. Established as a logging town before shifting to shipbuilding and logistics, the Emerald City is now known for its contributions to aerospace, software, biotech and cloud computing. And its status as a thriving tech ecosystem is attracting out-of-town companies looking to establish new tech and engineering hubs.
Key Facts About Seattle Tech
- Number of Tech Workers: 287,000; 13% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Amazon, Microsoft, Meta, Google
- Key Industries: Artificial intelligence, cloud computing, software, biotechnology, game development
- Funding Landscape: $3.1 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Madrona, Fuse, Tola, Maveron
- Research Centers and Universities: University of Washington, Seattle University, Seattle Pacific University, Allen Institute for Brain Science, Bill & Melinda Gates Foundation, Seattle Children’s Research Institute
