Position: Associate

Job type: Full-time

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Job content

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Purpose

The Associate Director, Biostatistics is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, biostatisticians can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBS Biostatistics Lead, the GBS Planning and Execution Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. Biostatisticians are individual contributors and report to a GBS Lead.

Primary Responsibilities
  • Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate
  • Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product
  • Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
  • Translates scientific questions into statistical terms and statistical concepts into layman terms
  • Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information
  • Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis
  • Communicates effectively with clinical and regulatory partners and external opinion leaders
  • Builds the external reputation of BMS R&D via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation
  • Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents
  • Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted
  • Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables
  • Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information
  • Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles
  • Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
  • Drives alignment at team (IPT) level, and escalates lack of team alignment to the GBS Lead for resolution
  • Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions
  • Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
  • Keeps up-to-date with state-of-the art applied statistical methodology
Impact

The Associate Director, Biostatistics is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.

Success Factors

Effectively demonstrates fully functioning capability in the follow areas

BMS Core Behaviors
  • Leads Strategically
  • Drives Performance
  • Innovates
  • Embraces Teamwork
  • Communicates Directly
  • Develops and Energizes People
GBS Leadership Success Factors
  • Leading and Managing Change
  • Influence and Impact Relationships
  • Decision Making
  • Building a Learning Environment
  • Emotional Intelligence
  • Managing and Developing Performance
  • Note Please refer to ancillary document for definitions and descriptions of aforementioned success factors
Experience
  • Pharma/Clinical Trials
  • A&R Experience
  • Project Leadership
  • Statistical training
  • Ph.D. (or equivalent) in Statistics or related field
  • >7 years Pharmaceutical/R&D or other related experience, including supporting regulatory filings
  • Experience planning and preparing for regulatory meetings
  • Expertise in statistical / clinical trials methodology as it relates to clinical development
  • Capability to solve complex statistical problems
  • Extensive data analysis planning, execution and delivery experience including co-ordination across multiple protocols
Primary Stakeholders

Stakeholder Area of Focus
  • IPT
  • Protocol development and defense at TA PRC
  • SAP/DPP development
  • Consultation on Ad Hoc Analysis requests
  • Interprets and presents study results
  • CSR preparation, data presentations, publications
  • Attends Data Team, as needed
  • GBS Lead
  • Matrixed reporting relationship, assignments, performance input
  • Contributes to GBS team discussions
  • Issue identification and resolution
  • PE Lead and PBO
  • Raises issues and risks regarding project, proposes solutions, and escalates as appropriate
  • Monitoring of vendor performance
  • GBS LT
  • Contributes to continuous improvement initiatives
  • Vendor
  • Acceptance of deliverables
  • Clarifies plans and specifications, serves as a point person for vendor’s staff
BMSONCRD

#GBDSStatistics

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.
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Deadline: 10-05-2024

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