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
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
Artificial Intelligence • Automotive • Greentech • Information Technology • Machine Learning • Software • Cybersecurity
Processes, codes, audits, and indexes service-provider invoices for fleet billing operations. Responsibilities include resolving invoice discrepancies, verifying approval limits, completing WACC requirements, processing rebills, performing VMRS coding and costing, managing purchase-order inquiries, and responding to overflow calls. The role requires accurate high-volume data entry, attention to detail, and communication with service providers and internal teams.
Top Skills:
TmcareVmrs
Artificial Intelligence • Automotive • Greentech • Information Technology • Machine Learning • Software • Cybersecurity
Processes, codes, audits, and indexes invoices for fleet services; resolves billing discrepancies with service providers, verifies approval limits, handles rebills and system resets, and responds to purchase order inquiries. The role requires accurate high-volume data entry, effective communication, and attention to detail in a fast-paced billing environment.
Top Skills:
TmcareVmrs
What you need to know about the Edinburgh Tech Scene
From traditional pubs and centuries-old universities to sleek shopping malls and glass-paneled office buildings, Edinburgh's architecture reflects its unique blend of history and modernity. But the fusion of past and future isn't just visible in its buildings; it's also shaping the city's economy. Named the United Kingdom's leading technology ecosystem outside of London, Edinburgh plays host to major global companies like Apple and Adobe, as well as a growing number of innovative startups in fields like cybersecurity, finance and healthcare.
