What are the responsibilities and job description for the Principal Biostatistician position at TechData Service Company LLC?
ResponsibilitiesAt project level, ensures the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements.Provide statistical support for multiple studiesParticipate in pre-IND and NDA/BLA activitiesAt study level, provide statistical input to study protocols, develop statistical analysis planAssist in writing relevant sections of the clinical study report and publicationMonitor internal and CRO project activities including timelines, deliverables and resourcesAbility to use SAS or R to perform efficacy analyses and validate important data derivations when necessary.Develop and implement department standards and lead process improvements Minimum RequirementsPhD or MS in Biostatistics or Statistics;At least 1 years of experience as statistician in Pharmaceutical or Biotechnology industries;Candidate with Intern experience in the pharmaceutical industry will be consideredGood knowledge of statistical programming languages (including SAS, R);Solid oncology and/or hematology experienceExperience with advanced study design or at least one NDA/BLA eCTDs or other global regulatory submissionsExperience as an independent lead statistician with responsibility for multiple studies or projectsExcellent interpersonal, leadership and communication skills and ability to work independently and collaboratively;Knowledge of SDTM/ADAM TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.Company Descriptionwww.techdataservice.com
Salary : $200,000 - $300,000