Job Objective (Primary responsibility):

1.    Lead, supervise, and oversee dynamic local programming team, ensure deliverable quality, and expedite the preparation of local compound regulatory submission.

2.    Support global projects as key programming contributor, collaborating with global teams to ensure seamless execution of project deliverables.

3.    Support global non-project initiatives related to process, standards or systems.

4.    Maintain institutional knowledge across compounds, support optimizing programming standards and process.

5.    Manage statistical programming team for recruiting and performance evaluations, provide training and administrative support.

Specific Responsibilities (Actions to achieve the Job Objective):

1.      Provide leadership and support to the local programming team on all statistical programming matters according to the project deliverables through the project milestones from study start-up to regulatory submission and approval, and post marketing support.

2.     Collaborate with global project teams and oversee in-house statistical programming team, to meet deliverable timeline and quality 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.

3.     Manage statistical programming team, provide technical and administrative

support.

a.    Establish and develop people in statistical programming team, including recruitment, retention, performance evaluations, and professional growth.

b.    Monitor, mentor, coach and keep good collaboration within the team and with global stakeholders to achieve section goal and meet overall business needs.

4.    Support global non-project initiatives related to process, standards or systems, Such as: Develop and maintain programming macros, tools to effectively support internal data review and monitoring, following global template and convention.

5.    Maintain institutional oncology knowledge, support optimizing programming SDTM, ADaMs and TLFs standards and process, to ensure implementation and full alignment.

6.    Lead team to support global study and submission programming activities, fostering collaborative culture and business driven mindset.

Competency:

1.    Solid oncology knowledge of drug development and in-depth knowledge of regulatory authority’s requirements

2.    Excellent SAS programming skills, other programming skills (e.g., R or Python) is preferrable.

3.      Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis

4.      Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials

5.    Strong communication and interpersonal skills, with the ability to collaborate effectively with global teams.

6.    Accountable, dedicated, persistent, and flexible.

7.    People management experience is required.

8.    Strong capabilities of work prioritization and deliver

results with parallel multiple tasks.

Education:

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

Experience:

·      Minimum 8 years and above for MS and above degree, minimum 10 years for BS degree

Language:

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

Computer Level:

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