Senior Manager, Statistical Programming - Główny Programista

Bristol-Myers Squibb; Warszawa; On-site; PLN 265,000 - 321,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Manager, Statistical Programming to lead programming teams for integration, analysis and submission of clinical data. The role requires robust expertise in SAS and R, CDISC standards, and collaboration across Global Biometrics & Data Sciences.

The position is based in Warsaw, with on-site requirements and potential hybrid options. You will drive programming strategies, ensure regulatory compliance and contribute to process improvements within a global

Qualifications

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences.
• Proficient knowledge of drug development, trial methodology and regulatory guidance.
• Broad expertise in statistical programming and computing strategies.

Responsibilities

• Provide programming leadership to clinical project teams and vendors.
• Develop and implement programming specifications and analyses to comply with regulatory requirements.
• Lead and support change management and process improvements within GBDS.

Skills

Statistical programming

Education

Bachelor's degree in statistics/biostatistics

Tools

SAS

R

XML

Pinnacle 21

Job description

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .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 practicesIndependently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standardsLeads / Supports the electronic submission preparation and reviewDevelops 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 activitiesCommunicates proactively and effectively around issues and risks and contributes to its remediationImprovement Responsibilities:Identifies, leads, and supports opportunities to enhance processes and technologyCommunicates proactively and effectively around issues and risks and contributes to its remediationMinimum Qualifications:Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences requiredAt least 7 years programming experience in industry including support of significant regulatory filingsProficient 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 dataBroad expertise in statistical programming and in developing computing strategiesIn-depth understanding of clinical data structure (e.g. CDISC standards) and relational databasesDemonstrated 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 membersPreferred Requirements:Management experience supervising technical professionals#LI-HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Warsaw - PL: zł264,960 - zł321,072The 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.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.Supporting People with DisabilitiesBMS 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 RightsBMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.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/Data ProtectionWe 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 you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail] . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.R1599982 : Senior Manager, Statistical Programming - Główny Programista