Penfield Search Partners
Contact: Barbara Day 201.784.9028 email@example.com
The company 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 them and make a difference. They 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, they create a better, more productive work environment. They believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
The biostatistics lead is a core member of the development team. Along with the clinical and regulatory leads, the lead is responsible to provide scientific and strategic leadership and has a shared responsibility for developing the clinical/regulatory strategy. Among other things, the lead provides strategic input into the design/planning of clinical trials, data analysis approaches, interpretation of findings and crafting of key messages. The lead typically represents the team in meetings with global regulatory agencies. The lead has accountability for the performance of the team and develops an effective partnership with the planning and execution lead to ensure the teams ability to execute with quality in agreed to timelines. The lead may have direct reports and is responsible for coaching and developing all members of their team. Leads may serve as members of the extended leadership team and contribute to the continuous improvement which includes but is not limited to recruitment of talent, improving processes and contributing to the strategic initiatives/directions.
- 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 organization by contributing and having influence in the development of capabilities, talent management and sharing of best practices. The 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 lead has, he or she may serve on the extended leadership team.
- Effectively communicates the mission and vision in a fashion that generates pride, excitement, and commitment within the team.
- 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 proposals, and contributes to the interpretation of trial results and development of the key messages and their communication.
- Together with the planning and execution lead, identifies project resource needs, and, in coordination with the development team, aligns teams approved objectives and timelines with the project level book of work and the allocation of resources to ensure effective delivery.
- Has accountability for the 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, clinical and regulatory partners, external opinion leaders and manages relationships and interactions with development alliance partners.
- Builds the external reputation of 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 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 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 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 company policies. Aligns objectives, feedback, and evaluation of performance with employees 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 with respect to issues of promotion, performance concerns and retention risks.
- Differentially recognizes, develops and rewards talent in roles that are critical to future growth through leadership opportunities and areas of visibility internally and externally.
- Contributes to development of a succession plan for critical positions.
- The contributions of the lead directly enhance the quality of our clinical research and result in better decision making within R&D. Through this, the company 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 teams resources. Leads will contribute to developing biostatisticians, P&E leads and programmers. They will influence and contribute to the strategic directions.
Success Factors – Effectively demonstrates fully functioning capability in the follow areas:
- Leads Strategically
- Drives Performance
- Embraces Teamwork
- Communicates Directly
- Develops and Energizes People
- Leadership Success Factors
- Leading and Managing Change
- Influence and Impact Relationships
- Decision Making
- Building a Learning Environment
- Emotional Intelligence
- Managing and Developing Performance
- 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 Masters 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.
The company recognizes the importance of balance and flexibility in our work environment. They offer a wide variety of competitive benefits, services and programs that provide their employees the resources to pursue their goals, both at work and in their personal lives.