Vice President Biostatistics & Programming

Catalyst Clinical Research

About The Position

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.

Requirements

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.
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.
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

Responsibilities

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.