Lead statistical Programmer

1)Primarily responsible for quality and timely delivery of SDTM and ADaM artifacts (Specifications, datasets, cSDRG, ADRG) and TFLs

2) Read and understand Clinical study protocol, Statistical Analysis Plan, Case Report Form (CRF), specifications and other study related documents.

3) Develop SAS programs to produce Analysis datasets, statistical tables, graphical representations, and data listings for individual study reports in accordance with the Statistical Analysis Plan (SAP)

4) Develop validation programs to validate outputs produced by other team members and perform validation on program code of other team members.

5) Provide support to Data Management in developing Edit check programs, listings or ad hoc reports as required

6) Develop, Debug Utility macros for reusability and efficiency

Skill Set -

1)Experience working on ADAM and TFL deliverables on multiple therapeutic areas and phases in clinical trials.

2) Experience creating and working with Utility Macros

3) Experience creating specifications

4) Experience with CDSIC standards including CDASH or SDTM/ADaM

5) Ability to work independently and as part of a team

6) Being open to new learnings and sharing with team members

7) Excellent communication skills [Written, Verbal, Interpersonal and organizational skills]

8) Proficient in using SAS EG/Studio for programming

9) Familiar with Unix environment and programming

10) Prior working experience in Vaccines or Oncology is an added advantage

11) Familiarity with multiple statistical procedures and functions to create TFLs