Manager, Statistical Programming - Starszy Programista

Bristol Myers Squibb EU Policy; Warszawa; On-site; PLN 238,000 - 288,000; Full time

Job summary

Bristol Myers Squibb in Warsaw, Poland, is seeking a Manager of Statistical Programming to lead and optimize programming for clinical projects across GBDS. You will design, develop and implement analytical solutions, and collaborate with global teams and external vendors.

The role requires a Bachelor’s in statistics or life sciences, at least 4 years of programming experience, and proficiency in SAS, R, and CDISC standards.

Qualifications

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• At least 4 years programming experience in industry.
• Proficiency in SAS, R or other programming languages to produce derived analysis datasets and TFLs.
• Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database.
• Demonstrated ability with MS Office, XML, Pinnacle 21.
• Demonstrated awareness of regulatory, industry, and technology standards and requirements.
• Demonstrated ability to work in a team environment with clinical team members.

Responsibilities

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs
• Provide comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
• Support the 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 GBDS deliverables by applying standards and complying with regulatory requirements, guidance and SOPs
• Identify opportunities for increased efficiency and consistency within GBDS and vendor interactions
• Independently lead and/or perform programming assignments across multiple projects with minimal supervision
• Support improvement initiatives

Skills

SAS programming

R programming

CDISC standards

Regulatory knowledge

Team collaboration

Linux

Education

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

Tools

MS Office

XML

Pinnacle 21

Job description

Working with Us

Challenging. 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.

Manager, Statistical Programming - Starszy Programista

Provides comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Managers of Statistical Programming develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.

Responsibilities

• Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs
• Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
• Support the electronic submission preparation and review
• Reviews 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; Assesses impact on programming activities
• Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers
• Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices
• Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors
• Independently leads and / or performs 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 required.
• At least 4 years programming experience in industry.
• Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs.
• Have in-depth understanding of clinical data structure (e.g. CDISC standards) and relational database.
• Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.
• Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
• Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
• Have good understanding of regulatory, industry, and technology standards and requirements.
• Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
• Demonstrated 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 (e.g. NDA, BLA, MAA)
• Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
• Experience in other software packages (e.g. R)
• Experience with the Linux operating system

Compensation Overview

Warsaw - PL: zł237,830 - zł288,194

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.

Uniquely Interesting Work, Life-changing Careers

With 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 Protocol

BMS 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 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 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 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 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.

R1599980 : Manager, Statistical Programming - Starszy Programista