Statistical Programmer

1 day ago

India CosMic IT Full time

Full Time
- India
- Posted 11 months ago
- Applications have closed
- CosMicIT
**CosMic IT**
- Find Your Dream Job Here_

Hello #Everyone,

We at #CosMicIT are looking for #Statistical Programmer

Language: #English

Locations: #India

Summary:
R/Python exp/knowledge, knowledge/exp of eCRF & SQL.

1. 1 to 4 years of experience in programming related activities for clinical studies (Phase I to IV) and publication

2. Advance knowledge of Base SAS, SAS / STAT, SAS /Graph modules and SAS Macros

3. Create specifications as per the standards for SDTM, ADaM datasets, pooled datasets, ISS/ISE datasets

4. Develop and/or validation of analysis datasets, tables, listings and figures for both safety and efficacy parameters

5. Develop and maintain study level macros.

6. Lead programming activities with guidance from SME/Lead statistical programmer.

7. Contribute to training and mentoring initiatives.

8. Audit readiness

Major Activities

1. Create and/ or review derive data specifications as per the standards for SDTM, ADaM datasets and pooled analysis (ISS/ISE) datasets

2. Perform development and validation of analysis dataset, tables, listings and figures for both safety and efficacy parameters

3. Understand and comply with ICH-GCP guidelines, core operating procedures and work instructions.

4. Ensure all programs are compliant with the SOPs and project specific guidelines

5. Provide support in developing ad hoc reports as required

6. Maintain quality and timelines of programming related deliverables

7. Update project related documentation regularly

8. Track and follow up on all issues raised.

9. Escalate unresolved issues to the project point of contact or Senior/Principal/Lead SAS Programmer.

10. Communicate any data queries or errors to appropriate team members

11. Mentor new team members on statistical programming activities and process related activities if required.

12. Participate to process improvements related activities

13. Communicate with clients effectively

14. Communicate with other departments and/or groups effectively

15. Participate / facilitate knowledge sharing sessions

16. Participate / facilitate trainings and other learning initiatives

Any references would also be accepted.

Regards,

CosMicIT GmbH, Germany

CosMicIT Informatics India Pvt Ltd.

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