Manager, Statistical Programming

Working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day across departments. From optimizing a production line to breakthroughs in cell therapy, this work transforms patients’ lives and career trajectories. You will have the chance to grow through opportunities uncommon in scale and scope, alongside high‑achieving teams.

Bristol Myers Squibb recognizes the importance of balance and flexibility. We offer a competitive benefits program that supports life both at work and in personal life.

Responsibilities

• Provide comprehensive programming support for project teams, including the development of programming strategies, standards, specifications and programmed analysis.
• Support electronic submission preparation and review.
• Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; assess impact on programming activities.
• Interact with vendors regarding project standards, programming conventions, programming specifications and file transfers.
• Provide leadership for ensuring quality of Global Biometric and Data Sciences deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices.
• Identify opportunities for increased efficiency and consistency within GBDS and interactions with strategic vendors.
• Independently lead or perform programming assignments across multiple projects with minimal supervision.
• Support improvement initiatives.

Minimum Requirements

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences.
• At least 4 years of programming experience in industry.
• Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs.
• In‑depth understanding of clinical data structure (e.g., CDISC standards) and relational database.
• Proficient in software tools and applications, e.g., MS Office, XML, Pinnacle 21.
• Ability to handle and process upstream data (multiple data forms, workflow, eDC, SDTM).
• Ability to provide outputs to meet downstream requirements (ADaM, Data Definition Table, e‑submission).
• Good knowledge of regulatory, industry, and technology standards and requirements.
• Good understanding of statistical terminology, clinical tests, medical terminology and protocol designs.
• Ability to work in a team environment with clinical team members.

Preferred Requirements

• Minimum of 4 years clinical/statistical programming experience within pharmaceutical clinical development supporting regulatory filings (NDA, BLA, MAA).
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements.
• Experience with other software packages (e.g., R).
• Experience with the Linux operating system.

Job Details

Senior level: Mid‑Senior level

Employment type: Full‑time

Job function: Design, Art/Creative and Information Technology

Industries: Pharmaceutical Manufacturing

Location: Warsaw, Mazowieckie, Poland

Equal Employment Opportunity

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations and ongoing support. If you require accommodations, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our equal employment opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws.

BMS recommends that all employees be fully vaccinated for COVID‑19 and keep up to date with boosters.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Occupancy Requirements

Roles are categorized by occupancy: Site‑essential, Site‑by‑design, Field‑based and Remote‑by‑design. The required onsite presence is determined by the nature and responsibilities of the role.