Senior Statistical Programmer I

Alexion Pharmaceuticals, Inc.; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. is seeking a Senior Statistical Programmer I to lead the development and validation of programs creating SDTM and ADaM datasets and generate Tables, Listings, and Figures for analysis.

The role requires strong SAS/Base/Macro/STAT skills, ability to work independently, mentor junior staff, and ensure adherence to ICH, GCP, and 21 CFR Part 11 standards in a collaborative environment. Office-based with three days in Bengaluru.

Qualifications

• 3+ years of statistical programming experience in pharma/biotech/CRO.
• Proven ability to develop and validate SDTM/ADaM datasets and analysis outputs.
• Strong SAS programming skills and knowledge of CDISC standards.

Responsibilities

• 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.

Skills

Statistical programming

Independent work

Mentoring

Regulatory compliance knowledge

Communication skills

Tools

SAS/Base

SAS/Macro

SAS/STAT

SAS/Graph

SAS/SQL

Relational Databases

Job description

Senior Statistical Programmer I

Location: Manyata Embassy Park, Bangalore

Career Level: D

Introduction:

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. The 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 3years 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.

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.

Alexion is proud to be an Equal Employment Opportunity and Affir 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 lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (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 an interactive dialogue with Alexion regarding an accommodation, please contact [e-mail]. Alexion participates in E-Verify.

Alexion is proud to be an Equal Employment Opportunity and Affir 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 status,pregnancy, (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 [e-mail]. Alexion participates in E-Verify.