Principal Programmer

14 hours ago

Bengaluru Karnataka, India AstraZeneca Full time

**Job Title: Principal Programmer - Statistical Programming**:
Introduction to role:
Are you ready to take on a pivotal role in statistical programming? As a Principal Statistical Programmer, you'll be at the forefront of developing and validating programs that create datasets conforming to Alexion and ADaM specifications. Your expertise will drive the creation of Tables, Listings, and Figures for efficacy data analysis, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. You'll lead programming efforts, represent Clinical and Statistical Programming in meetings, and mentor fellow programmers. This is your chance to integrate statistical concepts with SAS Programming efficiently and effectively

**Accountabilities**:

- Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
- Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
- Develop and validate technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs based on Protocol SAP.
- Independently develop and validate programs that generate efficacy tables, listings, figures/graphs using Alexion specifications.
- Supervise/manage external vendors and contract programmers.
- Oversee progress of programming activities.
- Review, maintain, and approve protocol-specific documents as necessary.
- Provide guidance and mentoring to peer and junior-level Programmers.
- Act as the primary department contact, when necessary, to ensure 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**:

- Bachelor’s Degree (Minimum) or Master’s Degree (preferred) in Biostatistics, Statistics or another related discipline
- Minimum of 7 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
- Expertise in using SAS/Base, SAS/Macro, SAS/STAT.
- Knowledge of SAS/Graph, and SAS/SQL
- Knowledge of:

- SDTM and ADaM
- Relational Databases.
- Good Clinical Practices.
- Good Programming Practices.
- 21CFR Part 11 Standards.
- Integrated Summary Safety/Efficacy Analyses.
- Safety data and Coding Dictionaries (MedDRA and WHODD).
- ICH eCTD format.

At AstraZeneca, we play an essential role in helping patients who need it the most. Our high exposure roles allow us to shape end deliverables while embracing global opportunities across all Therapy Areas. With a restless drive for improvement, we foster an inspiring learning environment where every setback is a chance to innovate. Our courageous team speaks up, shares opinions, and makes bold decisions that could change patients' lives. We combine specialist knowledge with curiosity, always searching for better ways to achieve the best results. Here, dedication and motivation are key as we navigate unknowns with resilience.

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