Senior Manager, Statistical Programming - Główny Programista

Bristol-Myers Squibb Co; Województwo mazowieckie; Hybrid; PLN 265,000 - 321,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Bristol Myers Squibb is seeking a Senior Manager, Statistical Programming to lead programming strategies for global clinical projects in Warsaw. You will guide a team, develop ADaM/TFLs, ensure regulatory filings, and partner with GBDS and external vendors in a hybrid work model.

The role requires a strong background in SAS, CDISC, and statistical programming, with 7+ years in industry and a degree in statistics or life sciences.

Qualifications

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences.
• At least 7 years programming experience in industry including support of significant regulatory filings.
• Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts.

Responsibilities

• Provide programming leadership and support to clinical project teams and vendors, ensuring regulatory compliance.
• Develop, validate, and maintain complex programs and utilities per specifications.
• Lead electronic submission preparation and review.
• Create robust programming specs (e.g. ADaM).
• Review statistical plans and data presentation plans for project alignment.

Skills

Statistical programming

SAS

R

CDISC

Regulatory submissions

Team collaboration

Education

Bachelor’s degree in statistics/biostatistics/mathematics/computer science/life sciences

Tools

MS Office

XML

Pinnacle 21

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Senior Manager, Statistical Programming - Główny Programista provides comprehensive programming expertise to clinical project teams to lead statistical programming teams and support the development, regulatory approval and market acceptance of Bristol Myers Squibb products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Senior Managers develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.
Senior Managers of Statistical Programming also support and lead improvement initiatives. They proactively plan, implement, and identify issues/risks and provide remediation strategies to facilitate decision making. Senior Managers also lead and support the change management process (e.g. communication, training, stakeholder engagement).
This position may include functional management responsibilities. They also support the evaluation and recruitment of potential employees.

Key Responsibilities:

• Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices

• Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards

• Leads / Supports the electronic submission preparation and review

• Develops unambiguous and robust programming specifications (e.g. ADaM specifications)

• Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities

• Communicates proactively and effectively around issues and risks and contributes to its remediation

• Improvement Responsibilities:

• Identifies, leads, and supports opportunities to enhance processes and technology

• Communicates proactively and effectively around issues and risks and contributes to its remediation

Minimum Qualifications:

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required

• At least 7 years programming experience in industry including support of significant regulatory filings

• Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data

• Broad expertise in statistical programming and in developing computing strategies

• In-depth understanding of clinical data structure (e.g. CDISC standards) and relational databases

• Demonstrated proficiency in using SAS, R or other programming languages to produce analysis datasets and TFLs and in using other software tools and applications (e.g. MS office, XML, Pinnacle 21)

• Demonstrated ability in processing of upstream data (e.g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e.g. ADaM, TFLs, e-submission components)

• Demonstrated ability to work in a team environment with clinical team members

Preferred Requirements:

• Management experience supervising technical professionals

#LI-Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Warsaw - PL: zł264,960 - zł321,072

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1599982 : Senior Manager, Statistical Programming - Główny Programista