Associate Director, Biostatistics FSP

Cytel

Multiple Locations

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.

Responsibilities

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

Qualifications

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