Who Are You? An experienced Associate Director, Biostatistics with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across your region. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is but always push clinical development forward to what it could be. You motivate others to do the same. 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: The Associate Director, Biostatistics is responsible for statistical activities in support of clinical trials (phase 2 and 3), including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. As an Associate Director, Biostatistics, your responsibilities will include: Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidate and provides input on clinical development plans. Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials. Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts. Contributes to or prepares statistical analysis plans. Collaborates with Data Management, Clinical Development and Clinical Operations on design of eCRFs. Provides statistical guidance on conduct of ongoing trials. Collaborates with Statistical Programmers on summary and analysis of trial data. Writes ADS and ad hoc analysis specifications. Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc. Represents sponsor in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders Contributes to scientific articles, summarizing data collected in Alnylam trials. Participates in other activities and meetings to support Biostatistics and the Development Team as needed. Consults with Research & Preclinical colleagues on statistical questions in their work. Manages CRO statistical and programming support. 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: Ph.D. in Biostatistics or Statistics or Equivalent with proven pharmaceutical biostatistics experience; or MS with at least 10 years relevant experience. Excellent written and oral communication and presentation skills. Experience programming in SAS. Interest in and basic understanding of biology and biological processes, including RNAi. Experience in clinical development through Phase 3 (NDA submission). Experience as lead statistician for a compound. Understanding of ICH GCP as well as general knowledge of industry practices and standards. Proficiency in R programming language and other statistical software, including EAST. Experience with CDISC, including SDTM, ADaM, CDASH. Experience in representing sponsors in meetings with interaction with US FDA and international regulatory authorities. Experience designing and conducting adaptive trials. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.