Job Objective (Primary responsibility):

Under the guidance of study/project lead, perform statistical programming support, develop aCRF; generate/validate SDTM/ADaM datasets/TFLs following data specifications and TFL shells and help preparing submission data package.

Specific Responsibilities (Actions to achieve the Job Objective):

Under the guidance of study/project lead, perform statistical programming support for pivotal studies and Integrated Summary of Safety and Efficacy (ISS/ISE) for- oncology submission compounds, and to expedite the preparation of oncology compound regulatory submission., Responsibilities include:

a.    Perform in-house statistical programming activities: such as, create aCRF; develop independent production/validation programs for SDTM/ADaM/TLFs following the speciations and shells; help preparing submission data package to ensure compliance with CDISC standards and submission requirements.

b.    Generate/validate adhoc and exploratory analysis in support of primary publications and business decisions. Prepare regulatory authority’s requested analyses and help submission team in quick turnaround in response to regulatory agencies.

Competency:

1.    SAS programming skills or other programming skills (e.g., R or Python) preferred.

2.    Basic knowledge of pharmaceutical industry, clinical trials, ICH, and CDISC standard preferred.

3.    Ability to prioritize work and meet deadlines.

4.    Capability to work and communicate in a global project team environment.

5.    Strong organization skills.

Education:

MS in Statistics or equivalent degree in statistics/biostatistics, mathematics, computer science or related discipline.

Experience:

·      Minimum 2 years for BS degree, Competent SAS or other coding skills with MS or above degree

Language:

Excellent language skills in both English and Chinese (fluent in verbal and written).

Computer Level:

Basic SAS programming skills, and with good command of computer.