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Senior Statistical Programmer II

Senior Statistical Programmer II

Astrazeneca

7 - 12 years

7 - 11 Lacs

Bengaluru / Bangalore, Karnataka, India

Posted:2 days ago| Platform: Foundit logo

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Skills Required

Statistical Programming (SAS) ADaM/SDTM Standards clinical data analysis Regulatory Compliance (21CFR Vendor Management Relational Databases

Work Mode

On-site

Job Type

Full Time

Job Description

Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM, and analysis datasets based on Alexion or ADaM specifications. Support development and validate technical programming specifications for tables, listings, figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas and thoughts towards the optimization of standard operating procedures. Lead team meetings when appropriate. Any other activities as required. Essential Skills/Experience: Minimum of 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Proven ability to: Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Independently and collaboratively resolve problems Clearly communicate processes and standards with management and team members High competence in using SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL Knowledge and implementation of: SDTM and ADaM principals Relational Databases. Good Clinical Practice principals. Good Programming Practice principals. 21CFR Part 11 Standards principals. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format.

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Astrazeneca

www.astrazeneca.com

Pharmaceutical Manufacturing

Cambridge Cambridgeshire

10001 Employees

48 Jobs

Key People

Pascal Soriot

Chief Executive Officer
Mene Pangalos

Executive Vice President, BioPharmaceuticals R&D
Marc Dunoyer

Chief Financial Officer
R&D

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