Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.
Position Responsibilities/ Accountabilities:
- Provide executive oversight on multiple clinical research projects and client relationships.
- Provide senior management support for broad-based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations.
- Provide advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project reporting applications that are supported by the department.
- Represent the department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, bid defense meetings, and be on the podium at industry events.
- Set strategy, develop, lead, and oversee the global department.
- Develop and track metrics on productivity and quality, and create strategies and best practices.
- Hire, supervise, and mentor biostatistics and programming leaders to effectively manage projects and staff.
- Develop and maintain Standard Operating Procedures and other departmental processes and procedures in accordance with guidelines and regulations to ensure quality deliverables.
- Drive commercial growth for the business and partner with commercial colleagues effectively.
- Provide strategic input to technology for current and future state.
- Develop study-specific bids that demonstrate an understanding of each client’s needs in a creative, innovative, efficient, and effective manner.
- Oversee operational execution of biostatistics and programming activities within the scope of the contract.
- Maintain an awareness of project issues and support teams as needed to maintain a positive relationship with clients. Act as a point of escalation as needed.
- Provide financial oversight for the Biostatistics and Programming department.
- Develop and oversee departmental staff (activities to include interviewing, terminations, promotions, training, personnel growth and retention plans, performance appraisals, goal setting, and salary adjustments).
- Supervise and mentor reporting staff in tasks and activities to develop the team structure and enhance departmental and project performance.
- Review and approve non-billable travel requests for the data management team and maintain department utilization.
- Act as a biostatistics and programming champion within the company.
Managerial Requirements/ Responsibilities:
Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary.
Position Qualification Requirements:
Education: Master’s degree, equivalent, or higher in biostatistics or a related field. A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above.
Experience:
- A minimum of 15+ years of relevant work experience
- A minimum of 7+ years of biostatistics and programming line management experience.
- Previous experience in a pharmaceutical research or CRO setting required.
- Previous experience in multiple therapeutic areas.
Required Certifications: N/A
Required Skills:
- Knowledge of clinical trial study design and multiple therapeutic areas, including oncology.
- Advanced knowledge of SAS and other specialist software.
- Able to work independently and direct various teams and committees.
- A high degree of accuracy and attention to detail.
- Proficient with Microsoft Office Suite.
- Excellent written and oral communication skills.
- Excellent presentation skills.
- Strong organizational, problem-solving, and analytical skills.
- Ability to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Proven ability to handle multiple projects and meet deadlines.
- Strong interpersonal skills.
- Global communication and time zone awareness.
- Ability to work effectively with a diversity of individuals at all organizational levels.
- Commitment to excellence and high standards.
- Creative, flexible, and innovative team player.
- Ability to travel for meetings or training activities.
- Ability to travel internationally may be required.
- Develop and guide implementation of departmental objectives and strategies.
- Proven ability to effectively manage and mentor junior staff.
- Ability to effectively engage with executive leadership.
- Experience with financial and budget management.
- Commercial experience.
