▷ Buen Salario Senior Biostatistician Fsp

Join to apply for the Senior Biostatistician FSP role at Cytel.Who Are You? An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited and enthusiastic, motivate your teams to do great work, collaborate easily with clients, and never settle for what is; you always push clinical development forward to what it could be.Job DescriptionPosition Overview Working fully embedded within one of our pharmaceutical clients, the Senior Biostatistician will be dedicated to a global pharmaceutical client driving the next generation of patient treatment, with support from Cytel. Senior Biostatisticians perform ad‑hoc or exploratory analyses to support submission or health authority questions. Experience in regulatory work is a bonus; exposure to translatingregulatory questions into statistical problems and collaborating with clinical and regulatory colleagues is valuable. The role supports medium‑complexity clinical trials, from design to archival, and involves project‑level activities.Responsibilities Providing statistical support to clinical studies.Participating in the development of study protocols, including design discussions and sample size calculations.Reviewing CRFs, data review guidelines, and developing statistical analysis plans (SAPs), analysis datasets and TLG specifications.Performing statistical analyses and interpreting statistical results.Preparing clinical study reports, including integrated summaries for submissions.Utilizing strong communication skills to present and explain methodology and decision consequences.Understanding and following FDA regulations affecting clinical trial data reporting, including Good Clinical Practice and electronic submission guidelines.Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.Participating in the development of CRFs, edit check specifications, and data validation plans.Providing review and / or authorship of data transfer specifications for external vendor data.Collaborating with internal and external functions (e.G., CROs, software vendors, clinical development partners) to ensure project timelines and goals are met.Providing review and / or authorship of SOPs or work instructions related to statistical programming practices.Qualifications Master's degree in statistics or a related discipline; Ph.D. strongly desired.5+ years supporting clinical trials in the pharmaceutical or biotechnology industry.Strong desire for experience working with a CRO.Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.Good SAS programming skills for QCing critical outputs, efficacy / safety tables, and close collaboration with programmers; knowledge of R programming is a plus.Solid understanding and implementation of CDISC requirements for regulatory submissions.Expertise in ADaM specifications generation and QC of datasets.Ability to build strong external and internal relationships and motivate a regional or global team.Effective communicator : able to explain methodology and decision consequences in lay terms.#J-18808-Ljbffr