GBS Biostatistics Lead, Global Biometric Sciences
The GBS Biostatistics Lead is a core member of the development team. Along with the clinical and regulatory leads, the GBS Lead is responsible to provide scientific and strategic leadership and has a shared responsibility for developing the clinical/regulatory strategy. Among other things, the GBS Lead provides strategic input into the design/planning of clinical trials, data analysis approaches, interpretation of findings and crafting of key messages. The GBS Lead typically represents GBS in meetings with global regulatory agencies. The GBS Lead has accountability for the performance of the GBS team and develops an effective partnership with the GBS Planning and Execution Lead to ensure the team's ability to execute with quality in agreed to timelines. The GBS Lead may have direct reports and is responsible for coaching and developing all members of their team. GBS Leads may serve as members of the GBS Extended Leadership Team and contribute to the continuous improvement of GBS, which includes but is not limited to recruitment of talent, improving processes and contributing to the strategic initiatives/directions of GBS.
- Core member of an FDT/EDT/LCMT and key subteams (eg, CDT, KIM). Contributes to all aspects of the development strategy. Partners with the team to prepare a development strategy that will enable the effective and safe utilization of the product.
- Assumes a leadership role within the GBS organization by contributing and having influence in the development of GBS capabilities, talent management and sharing of best practices across GBS. The GBS Lead serves as a model of scientific and strategic engagement for their team.
- Dependent on experience, scope of the role/team and sphere of influence that the GBS Lead has, he or she may serve on the GBS Extended Leadership Team.
- Effectively communicates the GBS Mission and Vision in a fashion that generates pride, excitement and commitment within GBS.
- Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments that impact the development team.
- Oversees the selection of trial designs, endpoints, statistical analysis strategy, development of DMC proposals, and contributes to the interpretation of trial results and development of the key messages and their communication.
- Together with the GBS Planning and Execution Lead, identifies project resource needs, and, in coordination with the development team, aligns team's approved objectives and timelines with the GBS project level book of work and the allocation of GBS resources to ensure effective delivery.
- Has accountability for the GBS team (internal and/or external) to effectively deliver on both scientific accountabilities and operational tasks (e.g. tables, figures, listings), while maintaining compliance with global standards, SOPs and established work processes.
- Coordinates the ad hoc analysis process and has decision making authority on acceptance of new analyses.
- Effectively communicates with internal scientific governance bodies (e.g. CSC, BDOC), clinical and regulatory partners, external opinion leaders and manages relationships and interactions with development alliance partners.
- Builds the external reputation of BMS R&D via external interactions (academic relationships, conference presentations, governmental research organization reviewer, etc).
- Presents or responds to questions at Global Regulatory Meetings
- Manages the GBS project team to take advantage of opportunities, overcome obstacles, and achieve program milestones. Facilitates the development of innovative solutions to both broad development issues and statistical issues.
- Contributes to GBS strategic initiatives through participation on initiative teams and/or contributing in feedback sessions.
- Line/matrix management responsibilities:
- Effectively manages, develops, evaluates and retains direct reports, resulting in an increasing level of capabilities for the GBS organization.
- Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.
- Conducts objective setting, mid-year reviews and end of year discussions in compliance with BMS policies. Aligns objectives, feedback and evaluation of performance with employee's matrix manager, if applicable.
- Establishes a development plan with each direct report and meet as frequently as required to deliver timely positive/development feedback and coaching.
- Conducts, at a minimum, a monthly 1 on 1 with each direct report, focused on both project updates and developmental discussions. Periodically checks in with employees between planned discussions.
- Ensures compliance of direct reports with training requirements and all relevant SOPs.
- Recommends to and gains alignment of senior managers (GBS LT) with respect to issues of promotion, performance concerns and retention risks.
- Differentially recognizes, develops and rewards talent in roles that are critical to BMS and GBS future growth through leadership opportunities and areas of visibility within and external to GBS.
- Contributes to development of a succession plan for critical positions.
The contributions of the GBS Lead directly enhance the quality of our clinical research and result in better decision making within R&D. Through this, BMS will be able to make early and quality decisions on its assets and ultimately have improved success rates for regulatory approvals and enhanced market acceptability. By managing stakeholder relationships, the effectiveness of the development team will be enhanced, with issues being resolved rapidly, resulting in more effective use of all the team's resources. GBS Leads will contribute to developing biostatisticians, P&E leads and programmers. They will influence and contribute to the strategic directions of GBS.
Effectively demonstrates fully functioning capability in the follow areas:
BMS Core Behaviors:
o Leads Strategically
o Drives Performance
o Embraces Teamwork
o Communicates Directly
o Develops and Energizes People
GBS Leadership Success Factors:
o Leading and Managing Change
o Influence and Impact Relationships
o Decision Making
o Building a Learning Environment
o Emotional Intelligence
o Managing and Developing Performance
Note: Please refer to ancillary document for definitions and descriptions of aforementioned success factors
- Statistical expertise, medical/clinical trials knowledge, and project management skills.
- Significant academic training in statistics, biostatistics or related field. PhD degree in statistics or biostatistics or Master's degree with relevant experience preferred.
- > 7 years of Pharmaceutical/R&D or other related experience in planning and managing statistical aspects of clinical development projects and clinical trials reporting to support regulatory filings and market access.
- Excellent verbal and written communications skills.
- Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement, including the resolution of conflicts or their appropriate escalation.
- Demonstrated experience in designing and executing research activities in close collaboration with medical, clinical, regulatory and commercial partners.
- Ability to work successfully in cross-functional teams leading to successful global regulatory filings and approvals.
- Strong communication/presentation skills with ability to tailor the message to the key stakeholder for effective impact and influence.
- Ability to be flexible and adapt quickly to the changing needs of the organization.
- Ability to organize multiple work assignments and establish priorities.
- Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs.
Matrix and the potential to have direct management responsibilities.
Area of Focus
• Provides scientific and strategic leadership and input
• Model core BMS behaviors
• Partners in establishing clinical and regulatory strategies
• Recommends trial designs, statistical approaches to analysis, and that key messages/data interpretations align with results of analyses performed
• Decision (D) for SAP/DPP/EDSAPP and ad hoc request approval
• GBS team representative at internal scientific governance meetings (e.g. CSC, BDOC)
• GBS representative at global regulatory meetings
• Core Member / Co-Lead of CDT
• Partners for coaching and feedback
GBS project team
• Provides scientific leadership, sets project directions and establishes a culture of inclusion and mutual support
• Recognizes and celebrates contributions of team members
• Effectively partners with P& E Lead and enables their ability to drive the day to day effectiveness of the GBS team.
• Approves project plans and team's resourcing strategy.
• Assigns statisticians to work, consistent with their experience and skills
• Recommends and gains agreement on approaches to remediate deviations from approved project plans
• Partners for coaching and feedback
GBS TA Head, GBS Discovery Head, PBO
• Manages issues and risks regarding project and escalates as appropriate
• Partners for coaching and feedback
• Provides feedback on performance of vendors to PBO
• Ensures compliance of team with all SOPs and global/project standards
• Contributes to continuous improvement and strategic initiatives
• Contributes to the recruitment, retention and development of GBS staff
• Models BMS Core Behaviors and supports a culture of inclusion and mutual respect in GBS
• Ensures vendors understand project's scientific issues which can impact their ability to perform and deliver
• If required, works with the P&E Lead to resolve any day to day issues or conflicts that can impact the team's deliverables.