Manager Statistical Programming

Bristol Myers Squibb; Hyderabad; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Bristol Myers Squibb is seeking a Statistical Programmer to provide comprehensive programming expertise for clinical projects, focusing on designing and implementing technical solutions for data integration, analysis and reporting. This role reports to a Statistical Programming Manager and collaborates with DQS, vendors and cross-functional teams.

The position emphasizes delivering high-quality programming under regulatory guidelines and driving process improvements within Global Drug

Qualifications

• Degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred
• Strong SAS programming skills and clinical trial knowledge preferred
• Ability to work within cross-functional teams and communicate effectively
• Flexibility and ability to adapt to changing project needs
• Excellent written and verbal communication skills
• Experience supporting regulatory submissions a plus

Responsibilities

• Provide programming support for clinical project teams and develop programming strategies and specifications
• Develop and implement solutions for integrating, analyzing and reporting clinical data
• Engage with vendors and cross-functional teams; provide guidance on analysis and reporting (A&R)
• Ensure quality and consistency of deliverables per DQS standards and regulatory guidance
• Identify opportunities to improve processes, standards and tools
• Support candidate evaluation and integration into the organization

Job description

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.

Position Summary

Statistical programmers provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of BMS products. This position is primarily responsible for the design, development and implementation of technical solutions for integrating, analyzing and reporting clinical data. Statistical programmers develop collaborative relationships and work effectively within DQS, with external vendors and members of cross-functional development teams. This position reports to a Statistical Programming Manager and has no direct supervisory responsibilities.

Duties/Responsibilities

• Provides comprehensive programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis. Drives the development and implementation of innovative strategies and technologies for flexible clinical trial programming.
• Reviews key planning documents (e.g., protocol, 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.
• Supports the development of unambiguous and robust programming specifications for internal and external programming work.
• Communicates effectively with DQS project and functional leadership concerning project issues (e.g. data, technical, timelines).
• Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers. When necessary, provides technical guidance to vendors supporting analysis and reporting (A&R) work. Provides support for acceptance of vendor deliverables.
• Builds successful partnerships and seamless interfaces within DQS and the broader Global Drug Development (GDD) organization. Provides timely and effective communication to project team members, highlighting DQS goals and priorities, ensuring work efforts parallel departmental objectives.
• Provides leadership for ensuring quality of DQS deliverables by consistently applying A&R standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices.
• Identifies opportunities for increased efficiency and consistency within DQS and across GDD. Contributes to globalization, improvement and standardization of processes, standards, and tools.
• Contributes to the technical evaluation of candidates and supports their successful integration into the organization.

Degree Requirements

• Undergraduate or Graduate degree in statistics, biostatistics, mathematics, computer science or equivalent experience preferred

Experience Requirement

• 5 - 8 years clinical/statistical programming experience within pharmaceutical clinical development
• Oncology Experience preferred

Key Competency Requirements

• Significant knowledge of SAS software (i.e. Base, Stat, Graph components) and general computing as related to clinical drug development.
• Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements.
• Ability to work successfully within cross-functional teams leads to successful global regulatory filings and approvals.
• Ability to be flexible and adapt quickly to the changing needs of the organization.
• Ability to organize multiple work assignments and establish priorities
• Excellent verbal and written communications skills

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:

Responsibilities

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.

R1605259 : Manager, Statistical Programming

Requirements: