180030101166
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Statistical Programmer
LocationPune
Job typePermanent
SalaryNA
Experience2 - 4 Years
Statistical Programmer I and Statistical Programmer II distinction is based upon education,
previous experience, and level of independence and expertise.
Job Specific Skills
Proficient generating tables, listings, and graphs from clinical trial databases using SAS.
Utilizes System Development Life Cycle (SDLC) for programming deliverables.
Proficient in SAS programming, SAS Base, SAS Macros.
Ability to adhere to E-Submission Standards, Guidelines and Regulations.
Mastery of SDTM standards including ability to write specifications.
Proficient in ADaM standards.
Proficient with MS Office applications.
Ability to adhere to ICH, 21CRF Part 11, and ISO 9001:2000 requirements.
Experience with pooling of data sets for submissions.
Experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP.
Member of project team.
Core Competencies for Level I/II Role
Level of Independence
o
Level I roles: Task and project level focus. Receives a moderate level of guidance anddirection. Requires support and guidance from the LM or Sr. Team Member
approximately 25% of the time or more.
o
Level II roles: Developing understanding of the Service Management processrequirements. Identifies and suggests opportunities for improvement related to Service
and/or Service Line at the project level.
Service Management: Developing understanding of the Service Management process
requirements. Identifies and suggests opportunities for improvement related to Service and/or
Service Line at the project level.
Customer Liaison/ Management: Interaction with the external and internal customer at the
project level. Some oversight and guidance from a more senior colleague or Manager regarding
best approaches with customer communication may be required.
Impact: Project level impact. Has a working knowledge and experience in own discipline. Project
level impact. Applies acquired job skills, policies, and procedures to complete substantive
assignments/projects/tasks of moderate scope and complexity; exercises judgment within
defined guidelines and practices to determine appropriate action.
Innovation/ Continuous Improvement: Uses existing procedures to solve routine or standard
problems. Contributes to process improvement.
Discretion/ Latitude: Exercises discretion related to communication with the customer. With
some guidance from more senior team member or a manager able to exercise proper judgment
related to disclosure of information based on appropriate audience.