Vice President Biostatistics & Programming

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology , a full-service oncology CRO,andmulti-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 .

As the Vice President, Biostatistics & Programming, you will be responsible for the strategic leadership, delivery, development, and oversight of the global Biostatistics & Programming department. This position provides daily supervision of and establishes operational framework for the global Biostatistics and Programming department. You will be responsible providing executive direction in planning, analyzing, and summarizing the results of individual clinical studies or groups of studies (integrated summaries). You will also coordinate the development and review of regulatory submissions (e.g., NDAs) in accordance with Standard Operating Procedures (SOPs) or study-specific guidelines. You will oversee the implementation of departmental strategies and initiatives, evaluate key performance indicators, participate in business development activities, and provide financial oversight of the department. You will have full responsibility for the effective recruitment, retention, and development of biostatistics and programming staff. This position serves as a key member of the Worldwide Flex Leadership Team.

Position Responsibilities/Accountabilities:

• Provide executive oversight on multiple clinical research projectsand 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 technicalexpertise, in conjunction with internal and external team members, to design, implement,validate, andmaintainproject reporting applications that are supported by the department.
• Representthedepartment 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 overseetheglobaldepartment.
• Develop and track metrics on productivity and quality,and createstrategies and best practices.
• Hire, supervise, and mentorbiostatistics and programmingleadersto effectively manage projects and staff.
• Develop andmaintainStandard Operating Procedures and other departmental processes and proceduresin accordance withguidelines and regulations to ensure quality deliverables.
• Drive commercial growth for the business and partner with commercial colleagues effectively.
• Provide strategic input totechnology for current and futurestate.
• Develop study-specific bids thatdemonstratean understanding of each client's needs in a creative, innovative, efficient, and effective manner.
• Overseeoperational execution ofbiostatistics and programmingactivities within the scope of the contract.
• Maintain an awareness of project issues and support teams asneeded tomaintaina positive relationship with clients. Act as a pointof escalation as needed.
• Provide financial oversight for theBiostatistics and Programmingdepartment.
• Develop and oversee departmentalstaff (activities to include interviewing, terminations, promotions, training, personnel growth and retention plans, performance appraisals, goal setting,and salaryadjustments).
• Supervise and mentor reporting staff in tasks and activitiestodevelop the team structure and enhance departmental and project performance.
• Review and approve non-billable travel requests for the data management teamandmaintaindepartmentutilization.
• Act as abiostatistics and programmingchampion within the company.

ManagerialRequirements/ 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 ora relatedfield.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+ yearsofbiostatistics and programming line management experience.
• Previousexperience ina pharmaceutical researchor CRO settingrequired.
• Previousexperience 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 andhigh standards.
• Creative, flexible, and innovative team player.
• Ability to travel for meetings or training activities.
• Ability to travel internationally may berequired.
• Develop and guide implementation of departmentalobjectivesand strategies.
• Proven ability to effectively manage and mentor junior staff.
• Ability to effectively engage with executive leadership.
• Experience with financial and budget management.