Details
Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes! Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward. We are hiring a remote AD Biostatistician to lead clinical trials for a major pharma company in the therapeutic area of Oncology. This position reports to the Director of Biostatistics in FSP Services business unit in Cytel. Your Impact As an Associate DirectorBiostatistician, you will provide statistics input into the strategy for new clinical trials and input into the end to end process of clinical trials, including protocol development, development & review of SAPs, associated TFL shells and specifications to programmers, review of ADaM and SDTM datasets, preparation, review, and interpretation of statistical analyses. What we are looking for: PhD in Biostatistics or related field. 8+ years' experience within the pharmaceutical industry (including contract research organizations (CROs), biotechnology or medical sector. Good understanding of clinical trial development studies with submission of marketing applications to regulatory agencies. Strong knowledge of research methodology and statistical approaches to analyzing data (e.g., time to event analyses, survival analysis), Bayesian methodology, simulation techniques. Possesses strong knowledge and pharmaceutical experience in the creation of clinical development strategic planning and the design and implementation of clinical studies. Experience with new drug application (NDA) submission to regulatory agencies, specifically concerning the description and analysis of each controlled clinical study, and the integration of summary information about the safety and efficacy (Integrated Summary of Safety and Integrated Summary of Efficacy) of a drug/device product. Successful track record of managing CROs conducting statistical aspects of clinical trials. Experience serving at a clinical study lead. Have working knowledge of Oncology clinical trials with CDISC SDTM, ADaM knowledge, SAP development, CSR writing, ad-hoc requests. Good knowledge of SAS programming and/or R. Ensuring data meets the required standards for regulatory submission to applicable agencies (for example, FDA). May include, but not limited to: Review of data (using tools such as Pinnacle 21) to ensure compliance with CDISC standards (ADaM and Define XML). Review of applicable Reviewers Guides Other Skills and Abilities: Eye for detail, ability to handle multiple tasks, strong organizational skills, with an ability to manage time and resources to ensure the successful achievement of pre-determined deadlines Flexibility in approach, while ensuring the delivery of high-quality work in a dynamic work environment, with competing priorities. Strong analytical and problem-solving skills. Utilizes a methodical and detailed approach in the review and consideration of procedures and data, without losing sight of the bigger picture. Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources for meeting all pre-determined timelines and outcomes Acts as an advisor to clinical/research scientists engaged in the scientific aspects of clinical development studies/projects and provides statistical programming support (via SAS, R, and other packages), as needed. Ability to oversee and manage a CRO's statistical analysis of assigned clinical trials. Able to interact effectively at all levels within the organization, as well as with external partners and clients. Proven ability to work independently with minimal supervision, as well as in a multi-cultural team environment. Must be an effective communicator (verbal and written): must be able to explain methodology and consequences of decisions in lay terms Team player with positive attitude and good communication skills Ability to be flexible when priorities change and deal with ambiguity. What's in it for you: You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development. You will be part of an exciting new chapter in Cytel's history with high growth and opportunities to learn and grow your career. Work with and leverage the best and brightest minds in the industry. "