Job
Description
JOB RESPONSIBILITIES : SDTM (end to end)
- Uses SAS or other software to generate summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and programming specifications.
- Works to ensure that outputs meet quality standards and project requirements.
- Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
- Keeps project team members informed of programming progress and issues requiring their attention.
- Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
- Maintains well-organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness.
- Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
- May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
- Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for the opinions of others.
- Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
- Completes project programming activities within the timeframe allotted by Lead Statistical Programmer and/or management.
- May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel, and monitors progress on programming deliverables.
- Assists with the transfer of deliverables.
- Performs other work-related duties as assigned.
- Minimal travel may be required.
QUALIFICATION REQUIREMENTS:
- Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience.
- Proficiency in programming in SAS or other required software, preferably in a clinical trial environment.
- Excellent written and verbal communication skills.
- Ability to read, write, speak, and understand English.
Hyderabad/Secunderabad, Pune, Gurgaon/Gurugram, Bangalore/Bengaluru