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
Healthtech • Information Technology • Security • Software • Cybersecurity
Owns Imprivata’s mobile product portfolio and business success, managing strategy, lifecycle, roadmap, feature prioritization, releases, adoption, and growth. Partners with Engineering, Marketing, Sales, Product Operations, and Customer Success to deliver secure, scalable enterprise SaaS products. The role requires mobile device and security knowledge, customer advocacy, data-driven decision-making, stakeholder communication, and use of AI tools and coding assistants to improve product workflows.
Top Skills:
AIAirwatchAndroidAutomationChatgptClaudeEnterprise SoftwareGithub CopilotiOSJAMFLlmsMicrosoft IntuneMobile Device ManagementObservabilitySaaS
eCommerce • Fintech • Food • Mobile • Social Impact
Design, build, and operate scalable distributed systems for real-time restaurant payment and financial workflows. Responsibilities include architecting reliable services, protecting sensitive financial data, improving observability and production performance, debugging distributed systems, participating in on-call rotations, applying AI-assisted engineering tools, collaborating cross-functionally, and mentoring engineers.
Top Skills:
DjangoExpressFastifyRuby on Rails
Cloud • Security • Software • Cybersecurity • Automation
Own strategic sales growth across U.S. Federal Civilian agencies, managing account plans, prospecting, pipeline development, forecasting, procurement cycles, proposals, executive presentations, and customer expansion. The role positions GitLab’s FedRAMP-authorized DevSecOps and AI capabilities against agency modernization, security, compliance, and mission requirements. It requires consultative selling, complex stakeholder management, federal procurement knowledge, and familiarity with secure software delivery and regulated environments.
Top Skills:
Agentic AiArtificial Intelligence (Ai)Continuous Delivery (Cd)Continuous Integration (Ci)DevsecopsFedrampGitlabSoftware Supply Chain Security
What you need to know about the Los Angeles Tech Scene
Los Angeles is a global leader in entertainment, so it’s no surprise that many of the biggest players in streaming, digital media and game development call the city home. But the city boasts plenty of non-entertainment innovation as well, with tech companies spanning verticals like AI, fintech, e-commerce and biotech. With major universities like Caltech, UCLA, USC and the nearby UC Irvine, the city has a steady supply of top-flight tech and engineering talent — not counting the graduates flocking to Los Angeles from across the world to enjoy its beaches, culture and year-round temperate climate.
Key Facts About Los Angeles Tech
- Number of Tech Workers: 375,800; 5.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Snap, Netflix, SpaceX, Disney, Google
- Key Industries: Artificial intelligence, adtech, media, software, game development
- Funding Landscape: $11.6 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Strong Ventures, Fifth Wall, Upfront Ventures, Mucker Capital, Kittyhawk Ventures
- Research Centers and Universities: California Institute of Technology, UCLA, University of Southern California, UC Irvine, Pepperdine, California Institute for Immunology and Immunotherapy, Center for Quantum Science and Engineering
