Responsibilities
1) Lead the statistical  programming  function

2)Provide strategic，technical and operational leadership for Statistical Programming support for al  clinical development programs spanning all phases of development including regulatory submissions.

3) Manaoes statistical proarammers，includina alobal proaram lead statistical proarammers and  people managers. and is a key member of the Statistical Operation team

4) Develop/maintain R&G’s standards and processes for Statistical   Programming function
contribute to development of cross-functional standards and processes

5) Forecast and manage Statistical Programming resource to meet current and future business  needs. establish and maintain vendor partnerships.

6) Accountable for the collaboration with Biostatistics to implement statistical analysis of all clinical  trial data, working closely with biostatistics on the development and validation of ADaM  specifications and datasets.define packages,and TLFs for analyses to support requlatory. medical affairs. and market access needs

7) Accountable for the infrastructure of R&G statistical proqramming environment  design and   implementation of standards and efficient procedures

8) Ensure proper role and contribution by Statistical Programming in various stages of clinical  studies, including review of case report forms ,review of statistical analysis plans,development of shells for tables,fiqures and listings,programming support of data cleaning,ad hoc and exploratory analyses,interim and final analyses   publications,etc

9)
Lead statistical programming efforts for NDA,EMA and other regulatory submissions,includinc SDTM and ADaMdatasets and associated define filestables/figures/listings for integrated summaries(Iss and ISE)etc

10) Create qroup goals and timelines and communicate them effectively across the entire
organization

11) Serve as lead statistical programmer for multiple projects,and work collaboratively with other functions and vendors to meet timelines for Statistical Proarammina deliverables

12) SAS programming expertcapability to resolve complextechnique issue 

13) Train and manage the Statistical Programming teams

14)Mentors statistical programmersincluding people managers.Promotes teamwork and close  collaboration with Biostatistics and Data ManagementCreates a productive work environment

15) Address clinical data submission questions/comments from FDA and other regulatory agencies.e16)Recruit and manage programmers as needede

17)Oversee and manage the progress and quality of all the statistical programming projects of R&G

18) Perform other duties asreguested bymanagement