Principal Statistical Programmer

Job Title: Principal Statistical Programmer

• Work Location: Manyata Tech Park Bangalore India

• Work Schedule: Three days onsite 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 crossfunctional 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 protocolspecific 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 protocolspecific documents as vital.

• Provide guidance and mentoring to peer and juniorlevel 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. Bachelors Degree or equivalent experience (Minimum) or Masters 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 lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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

Ready to make a difference Apply now to join our team!

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.