Senior Statistical Programmer I

Overview

Senior Statistical Programmer I will be a primary resource for developing and validating programs that create SDTM and ADaM-conforming datasets and Tables, Listings, and Figures (TLFs) for analysis, and will mentor programmers and external consulting resources.

What you'll do

• 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.

What you'll need

• Minimum of 3 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.
• Ability to independently and collaboratively resolve problems.
• Ability to 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 principles.
• Knowledge and implementation of relational databases.
• Knowledge and implementation of Good Clinical Practice principles.
• Knowledge and implementation of Good Programming Practice principles.
• Knowledge and implementation of 21CFR Part 11 Standards principles.
• Knowledge and implementation of Integrated Summary Safety/Efficacy Analyses.
• Knowledge and implementation of safety data and coding dictionaries (MedDRA and WHODD).
• Knowledge and implementation of ICH eCTD format.

Details

• Location: Manyata Embassy Park, Bangalore.
• Career Level: D.
• Work mode: on average a minimum of three days per week from the office.
• Duties are generally conducted in an office environment; requires general availability during standard business hours.