Senior Biostatistician

Organisation Description
EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field.
Description

This position provides statistical input into Phase II, III and IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. Provides statistical input into protocol/CRF development in all therapeutic areas at Serono (e.g., trial design, sample size estimation, randomization, statistical methods for protocols, query checks for clinical trial data). Write detailed statistical analysis plans for clinical trials as well as for integrated summaries of efficacy and safety. Analyze clinical trial data producing accurate results representing the outcome of the trial. Validate statistical output. Accurately interpret and clearly communicate statistical results and concepts to non-statisticians. Cco-author final integrated reports of clinical trial data writing thorough and clear statistical methods sections and producing the statistical appendix for the reports. Provide statistical output as required for manuscripts and ensure that the results are accurately interpreted in the publications. Provide input into statistical SOPs and general standardization efforts within the department (e.g. statistical methodology standards, standard data presentations. Participate in interactions with regulatory agencies as required. Collaborate effectively with members of clinical trial implementation teams and with Biometrics colleagues.
Language and EducationFluency in English Ph.D. in Statistics or Biostatistics with at least 2 years pharmaceutical/ biotechnology experience or a Masters Degree in Statistics Biostatistics with at least 5 years pharmaceutical/biotechnology experienceProfessional Skills and ExperienceWorking SAS knowledge and proficient in SAS statistical proceduresKnowledge of ICH statistical regulatory requirementsExcellent communication skillsPersonal Qualifications