Bristol Myers Squibb
Location
Secunderabad | India
Job description
Senior Managers of Statistical Programming provide 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. In this role, Senior Managers of Statistical Programming are responsible for managing employees: set objectives, manage performance, and provide meaningful coaching and feedback. 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
Managerial Responsibilities (if applicable):
Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS
Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager
Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements
Communicates with manager regarding promotions, performance concerns, and retention risks
Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results
Minimum Qualifications
Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required
At least 8 years programming experience in industry including support of significant regulatory filings
For US positions: US military experience will be considered towards industry experience
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 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
Job tags
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