Principal Statistical Programmer

**Job Title: Principal Statistical Programmer**
- Work Location: Manyata Tech Park, Bangalore, India
- Work Schedule: Three days on-site, two days remote (3/2)
- Career Level: E - Individual Contributor position.

**Introduction to role**

Are you ready to make a profound impact on patients' lives? As a Principal Statistical Programmer at Alexion, you will be a key player in developing and validating programs that create datasets conforming to Alexion and ADaM specifications. You will generate Tables, Listings, and Figures (TLFs) for efficacy data analysis, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. As a Programming Lead, you will represent Clinical and Statistical Programming in meetings with internal and external clients and cross-functional project teams. Additionally, you will mentor other Statistical Programmers, integrating 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/lead external vendors and contract programmers.
- Lead all aspects of progress of programming activities.
- Review, maintain, and approve protocol-specific documents as vital.
- Provide guidance and mentoring to peer and junior-level Programmers.
- Act as the primary department contact to ensure that department standards are implemented in all studies.
- Contribute ideas towards the optimization of standard operating procedures.
- Lead team meetings when appropriate.
- Perform any other activities as required.

**Crucial Skills/Experience**

1. Bachelor’s Degree or equivalent experience (Minimum) or Master’s Degree or equivalent experience (preferred) in Biostatistics, Statistics or another related field

2. Minimum of 7 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.

3. 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.

4. Knowledge of:

- SDTM and ADaM
- Relational Databases
- Good Clinical Practices
- Good Programming Practices
- 21CFR Part 11 Standards

**Desirable Skills/Experience**
- Knowledge of SAS/Graph, and SAS/SQL
- Integrated Summary Safety/Efficacy Analyses
- ICH eCTD format
- Safety data and Coding Dictionaries (MedDRA and WHODD)

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca's Alexion division, we champion diversity and foster an energizing culture where new ideas thrive. Our commitment to inclusion ensures that life-changing innovations can come from anywhere. We celebrate each other's successes and take pride in giving back to our communities. Here, your career is more than just a path; it's a journey to making a difference where it truly counts.