Associate Director, Biostatistics FSP

Cytel Inc•United States,

About The Position

As an Associate Director of Biostatistics, you will be dedicated to a major pharmaceutical client, working as an extension of its staff to support or lead clinical trials for drug development. You will have the opportunity to apply your experience and advanced statistical methods within the client's Global Therapeutic Statistics group. The role is fully embedded within the client, with Cytel providing support. You will provide statistical and development support and influence for the client's trials, contributing expertise to processes, clinical development plans, concept sheets, and protocols, and potentially overseeing work supported by other vendors. You will formulate integrated analytical approaches to mine data sources, use statistical methods and machine learning and deep learning algorithms to discover actionable insights, and automate processes to reduce effort and time for repeated use.

Requirements

Master’s degree in Statistics or a related quantitative discipline.
At least 7 years of experience supporting clinical trials in the pharmaceutical or biotechnology industry.
At least 3 years of recent experience in Phase II–III studies, including SAP development, sample size calculation, and TLF review.
Strong knowledge of adaptive design, group sequential methods, and statistical methods for count data.
Good understanding of the drug development process and cross-functional interfaces, with experience supporting end-to-end trial delivery from protocol input through CSR contributions.
Working knowledge of EMA, FDA, and ICH guidelines and regulatory expectations for clinical trials and submissions.
Proficiency in SAS and/or R for quality control of statistical outputs and collaboration with programming teams.
Excellent, effective communication skills and ability to interact effectively with cross-functional stakeholders and external partners.
Strong organizational and project management skills.
Ability to work independently, take ownership, and be accountable for study-level statistical activities and deliverables.

Nice To Haves

PhD.
Prior experience on Hematology studies.

Responsibilities

Lead statistical activities for assigned clinical trials, mainly Phase 3, independently from protocol design through reporting of results.
Represent the Statistics function on cross-functional trial teams and collaborate with cross-functional stakeholders.
Oversee internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
Contribute to or lead statistical activities including database lock and submission activities, safety reporting, ad hoc requests, and responses to regulatory questions.
Collaborate 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 quality control of datasets and deliverables, inferential statistical analyses, modelling and simulation, and exploratory analyses.
Coordinate statistical activities across studies within the assigned project, ensuring aligned objectives, consistent approaches, and on-time delivery.