Associate Director

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Wallingford TransitionBiostatistician, Global Biometric SciencesPurpose:

The biostatistician 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 Biostatistician 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

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com