Biometrician

Major Responsibilities：

• Justification: 1.List 1-8 working responsibilities to cover 3 key areas: concerning points, accountabilities and authorities and limitations; 2.Describe key tasks for each responsible item and make it as clear as possible for other people to understand this job’s main working scope and tasks.、
• Be responsible for assigned statistical tasks on clinical trials, e.g. clinical trial design/planning, analysis plan, reporting activities, exploratory analyses and additional analyses to support publications, and statistical consultation during the running phase (as applicable).
• Review and contribute to the preparation of protocols and CRFs, specifically related to the data management session (data management plan and statistics plan), visit schema and study design.
• Track clinical trial activities and milestones.
• Ensure timeliness and quality of deliverables for the assigned tasks on clinical trial deliverables.
• Follow processes and adhere to Novartis and project specific standards as well as Health Authority requirements (SOPs, Business Guidance, Master Analysis Plan, GCP, and regulatory guidelines) as appropriate.
• Establish and maintain sound working relationships and effective communication within the clinical trial team (locally and with other sites), customers (especially CRO’s) and peers (especially in clinical teams or Biometrics & Data Management Team).
• Communicate with CRO’s and perform acceptance checking of CRO deliverables as appropriate.
• Participate in non-clinical project activities [eg. Presentations within the team] as needed.
• Support the SSW [Study Specification Worksheet] development with an emphasis on data analysis and data management related items for outsourced studies
• To provide support on CRO selection and to oversee data management workflow, processes and Q/A activities for selected projects and liaise with CRO’s/3rd parties to ensure effective communication of deliverables and adherence to Novartis quality standards.
• To advise Clinical Development colleagues on data management issues

Requirement：

• At least Master’s Degree in statistics or an equivalent degree.
• At least 2 year of experience in clinical trials (maybe acquired at a CRO) or a related area (no prior work experience required for Ph.D.).
• Good communication skills, including ability to communicate in English verbally and in writing.
• Ability to give effective guidance to programmers.
• Knowledge of and experience in using statistical software, in particular SAS.