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.