We are looking for a principal biostatistician for our global biostatistics and data management team.

As a principal biostatistician, you will lead the statistical aspects of our clinical trials. The role will involve defining and implementing statistical techniques commonly used for oncology clinical trials, working on key department deliverables involving designing and analyzing clinical trials, and leading the statistical aspects for regulatory submissions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Modeling clinical data with Cox Models, Kaplan-Meier Estimates, competing risks
• Contribute to study design by incorporating adaptive design, superiority and non-inferiority trials, propensity score matching, and conducting meta-analyses.
• Contribute to protocol development in conjunction with clinical development and operations teams and responsible for assessing the feasibility of the study endpoints and developing the Statistical Analysis Plan (SAP)
• Report the study results in the Clinical Study Report (CSR)
• Oversight of the CRO and validate other vendors' statistical activities
• Provide statistical advice and manage statistical aspects of clinical and preclinical projects
• Approve statistical outputs: Table, Listing, and Figures (TLFs) and the analysis datasets produced by the statistical programming team using SAS
• Work within a multidisciplinary team and serve as a point of contact between clinical operation, CRO, and SAS programmers within the statistical department
• Provide statistical input for the study-related documents: study execution plans (including Data Management Plan), eCRF design and Edit Checks specifications, eCRF completion guidelines and data reconciliation plans
• Review SAS coding and specifications
• Other responsibilities as assigned

QUALIFICATIONS/KNOWLEDGE:

• Qualifications:

Ph.D./M.Sc. degree in Statistics or Biostatistics

• Knowledge:
• At least 5 years of experience leading statistical aspects in late-phase clinical trials, and oncology studies would be an advantage
• Excellent knowledge of common statistical techniques used in oncology clinical trials, with experience writing SAP and the statistical sections of the CSR
• Previous experience with FDA and/or EMEA submissions
• Excellent proficiency in programming with SAS and/or R
• Knowledge of ICH-GCP, CFR, CDISC, and other relevant regulations and guidelines
• Fluent in English (verbal and written) and excellent communication skills

OTHERS:

• Ability to work both independently and collaboratively
• Responsibility, detail-oriented, and creative with excellent organizational skills
• strong critical thinking and problem-solving skills