Manager 1 - Bio-stats & CDM Professionals

Location

Mumbai | India

Job description

Perform all statistical programming activities includes but not limited to CDISC SDTM and ADaM programming; creating summary reports, tables, listings and figures; adhoc programming activities.

Key responsibilities of the role:

1. Review Study documents and provide inputs from programming perspective that includes but not limited to Study Protocol, eCRF (electronic Case Report Form), Data Management Plan, Data Transfer specifications, Statistical Analysis Plan (SAP) and any other documents necessary to perform programming.
2. Ensure that the raw datasets are properly converted to CDISC SDTM formats by either creation or review of the programming performed by a CRO.
3. Prepare or review data definition documents such as define xml, SDTM annotated CRF and SDRG in order to compile a submission ready data package for regulatory submission.
4. Perform programming of CDISC ADaM (Analysis Data Model) and Tables, Figures and Listings defined by the SAP along with any other type of report programming necessary for the study team to meet objectives.
5. Assist Sr. Manager Programming in creation and maintenance of department procedures: Participate in departmental initiatives related to process building and improvement.
6. Work within SPARC, as necessary, to implement global programming and statistical analysis procedures, processes and standards.
7. Coordinate with Cross-functional teams for setting programming deliveries expectations.

Educational Qualification

M.Sc/B. Tech/M.Tech

Work Experience:

8 to 12 years in related field

Skills / Competencies

• Expert in SAS/Statistical programming with demonstrated experience using Base SAS, SAS Stat, Reporting and Graphical Procedures, Macro, SAS Version 9.2 or higher in a clinical trials setting.

Job tags

Salary