Leads statistical activities for Phase II–III clinical trials from protocol design through reporting and regulatory submissions. Develops statistical analysis plans, sample-size calculations, and reviews tables, listings, and figures. Oversees internal programmers and CRO contributions, applies SAS and R for analyses and quality control, and collaborates with clinical, data management, programming, and regulatory stakeholders. Coordinates statistical activities across studies and applies advanced statistical, machine learning, and modeling methods to support drug development.
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
Cytel Cambridge, Massachusetts, USA Office
Cambridge, MA, United States
Similar Jobs
Software • Analytics • Biotech
Leads biostatistical activities for Phase II–III clinical trials, from protocol design through reporting and regulatory submission support. Responsibilities include statistical analysis planning, sample size calculations, SAP development, TLF review, database lock support, safety reporting, regulatory responses, and oversight of programming or CRO work. Collaborates with cross-functional clinical teams and uses SAS or R for analyses, modeling, simulation, exploratory work, and quality control. Coordinates statistical activities across studies and applies advanced statistical and machine learning methods.
Top Skills:
Deep LearningMachine LearningRSAS
Cloud • Fintech • Food • Information Technology • Software • Hospitality
Leads an engineering team delivering Quoting, Catalog Management, and go-to-market technology. Oversees technical decisions, delivery planning, code reviews, quality assurance, release planning, incident resolution, stakeholder collaboration, and team development. Partners with Sales, Product, RevOps, and Data Analytics leaders while driving scalable solutions across Salesforce CPQ, Product Catalog, and related systems. Champions AI-assisted development and contributes to complex architecture and implementation efforts.
Top Skills:
Ai Development ToolsCi/CdETLGitPricing RulesProduct CatalogRestSalesforceSalesforce CpqSoap
Cloud • Fintech • Food • Information Technology • Software • Hospitality
Lead credit risk strategy for lending products by analyzing portfolio performance, identifying risk drivers, refining underwriting and pricing policies, and conducting A/B tests. Partner with Data Science to develop and monitor credit models, while building AI-enabled workflows that automate analysis and surface risk signals. Collaborate cross-functionally with Risk, Product, Engineering, Operations, and Data Science to support scalable fintech growth and compliant automated credit decisioning.
Top Skills:
A/B TestingAIHexLlmsLookerPythonRSQLStatistical ModelingTableau
What you need to know about the Boston Tech Scene
Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.
Key Facts About Boston Tech
- Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
- Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
- Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
- Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories
