Senior Statistical Programmer - Hybrid, Regulatory-Driven Data

Bristol-Myers Squibb Co; Denham; Hybrid; GBP 75,000 - 105,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Statistical Programmer in Uxbridge, UK, hybrid role with 50% onsite. You will drive programming for derived datasets, Tables, Figures and Listings, supporting regulatory submissions and data standards across Global Biometrics & Data Sciences.

Join a team delivering high-quality programming with autonomy, collaborating with cross-functional clinical teams and external vendors to ensure data integrity and timely regulatory packages.

Qualifications

• Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, or Life Sciences
• Demonstrated industry experience in statistical programming
• Strong proficiency in SAS for producing derived analysis datasets and TFLs
• In-depth understanding of clinical data structures, CDISC standards (SDTM, ADaM) and relational databases
• Hands-on experience with upstream data handling - multiple data forms, eDC, workflow, and SDTM
• Ability to deliver downstream outputs including ADaM datasets, Data Definition Tables, and e-submission packages
• Confidence with tools like MS Office, XML and Pinnacle 21
• A solid grasp of regulatory, industry, and technology standards
• Familiarity with statistical terminology, clinical trial methodology, medical terminology, and protocol designs
• A genuine team player - you communicate well, build bridges across functions, and make the people around you more effective
• Bonus: deep experience supporting global regulatory filings (NDA, BLA, MAA) and knowledge of end-to-end drug development processes
• Bonus: experience with R or other statistical programming languages
• Bonus: familiarity with Linux operating system

Responsibilities

• Write and validate SAS programs to generate derived analysis datasets and TFLs feeding regulatory decisions
• Contribute to electronic submission preparation (NDA, BLA, MAA) for pivotal regulatory milestones
• Review planning documents like SAPs and Data Presentation Plans to ensure clarity before programming starts
• Partner with vendors on programming standards, specifications, and file transfers
• Independently lead programming assignments across multiple projects with minimal supervision
• Spot opportunities to improve efficiency and consistency across GBDS

Skills

SAS

CDISC SDTM

ADaM

Relational databases

Upstream data handling

eDC

Pinnacle 21

MS Office

XML

Education

Bachelor's degree in Statistics/Biostatistics/Mathematics/Computer Science/Life Sciences

Tools

Pinnacle 21

MS Office

XML

R (bonus)

Job description

Bristol Myers Squibb is seeking a Senior Statistical Programmer in Uxbridge, UK, hybrid role with 50% onsite. You will drive programming for derived datasets, Tables, Figures and Listings, supporting regulatory submissions and data standards across Global Biometrics & Data Sciences.

Join a team delivering high-quality programming with autonomy, collaborating with cross-functional clinical teams and external vendors to ensure data integrity and timely regulatory packages.