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CORE JOB TASK

1) Provide statistical input into the clinical development of drugs.

2) Assist in developing the technical details of client proposed documents.

3) Participate in clinical study design and protocol development as the role of project statistician.

4) Ensures that project-related biostatistics and programming work is carried out in a timely and compliant manner.

5) Establishes and maintains effective working relationships with study teams, including data management personnel, statistical programmers, clinical research and regulatory personnel and corporate partners.

6) Develop and review Statistical Analysis Plan (SAP) and TLF mock shells for clinical studies.

7) Conduct statistical analysis and CSR validation.

8) Conduct statistical programming validation.

9) Review critical statistical documents and analysis deliverables

10) Develop and review statistical reports development for clinical studies.

11) Participate in and review randomization schedule development.

12) Provide statistical support for IDMC and other disciplines related to biostatistics.

13) Provide input in the preparation of scientific presentations and manuscripts.

14) Act as statistical consultant to clients and study team in related disciplines.

15) Carry out all activities according to SOPs working within the framework of the Quality management System and to Good Clinical Practice (GCP)

16) Train and mentor junior biostatisticians.

17) Perform other duties as requested by management.

18) Participate in process improvement, training, standards development and enhancing statistical technical expertise.

19) Interviewing and selection of potential candidates

20) Provide ongoing training and mentoring within Statistical analyst and junior statistician to ensure thorough knowledge of the processes used and ongoing technical development.

21) Manage the statistician resource and provide necessary support to project team

22) Support business development activities.

MINIMUM REQUIREMENTS

1) PhD in Statistics and related field with 3+ years’ experience

2) Master’s degree in Statistics and related field with5+ years’ experience in pharmaceutical industry

3) Good sense about statistical model

4) Excellent verbal and written communication skills, including formal presentation skills

5) Excellent analytical skills

6) Fluent in written and spoken English, CET6 is preferred

7) Hands on SAS skills in Base SAS, basic Macro programming and SAS/STAT.

8) Experience in development of SAS code or R code