Sr Statistical Programmer I

Alexion Pharmaceuticals; Bengaluru; Presencial; INR 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Alexion Pharmaceuticals in Bengaluru, India seeks a Senior Statistical Programmer I to develop and validate programs that create SDTM/ADaM datasets and TLFs for analysis, aligning with Alexion and CDISC standards.

The role requires strong SAS expertise (Base, Macro, STAT, Graph, SQL), adherence to ICH, GCP, and 21 CFR Part 11, and mentoring of junior staff. You will collaborate with cross-functional teams, manage external vendors, and contribute to SOP improvements in a standard office setting.

Formación

• 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.
• 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.

Responsabilidades

• 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.

Conocimientos

SAS/Base

SAS/Macro

SAS/STAT

SAS/Graph

SAS/SQL

SDTM/ADaM

Relational databases

GCP compliance

Programming standards

21 CFR 11

Herramientas

SAS/Graph

SAS/SQL

Descripción del empleo

Job Summary

The Senior Statistical Programmer I will be a primary resource for the development and validation of programs which create datasets conforming to Alexion and CDISC standards, as well as Tables, Listings, and Figures ( TLFs ) for analysis purpose. They will develop specifications to ensure statistical programming elements align with the overall deliverable. They will also ensure compliance with ICH guidelines, Good Clinical Practices, and regulatory requirements. They will support the Programming Lead and may represent Statistical Programming in meetings with internal and external clients and cross-functional project teams. The Senior Statistical Programmer will act as a mentor to Statistical Programmers and external consulting resource. They must demonstrate, at a minimum, a good ability to accurately integrate statistical concepts with SAS Programming in a most efficient and effective manner. They must be able to work independently.

You will be responsible for:

• 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.

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

You will need to have:

• 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.
• 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.

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.