Responsibilities

· At project level, ensures the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements.

• Provide statistical support to Clinical Development Plan for multiple compounds
• Participate in pre-IND and NDA/BLA activities
• At study level, provide statistical input to study protocols, develop statistical analysis plan
• Assist in writing relevant sections of the clinical study report and publication
• Monitor internal and CRO project activities including timelines, deliverables and resources
• Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
• Develop and implement department standards and lead process improvements

Minimum Requirements

• PhD or MS in Biostatistics or Statistics;
• At least 1 year of experience as statistician in Pharmaceutical or Biotechnology industries;
• Candidate with Intern experience in the pharmaceutical industry will be considered
• Good knowledge of statistical programming languages (including SAS, R);
• Solid oncology and/or hematology experience
• Experience with advanced study design or at least one NDA/BLA eCTDs or other global regulatory submissions
• Experience as an independent lead statistician with responsibility for multiple studies or projects
• Excellent 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.