Vice President, Oncology Biostatistics And Consulting

SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high-quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a valued partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance, and 401k matching (US), we are able to attract some of the most talented people in the industry.

This person will be a member of the SDC Management team. They provide strategic direction in support of company goals across Operations in Oncology trials. Directs departmental activities and maintains the statistical integrity of oncology clinical trials analyzed by SDC. Leads efforts in writing statistical sections of oncology protocols, providing statistical analysis strategy for clinical development plans, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, active member of DSMB (voting or non-voting member), writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Responsible for operational excellence in Biostatistics and Statistical Programming functions.

Primary Responsibilities

• Lead and provide oversight to key corporate oncology-focused initiatives within Biostatistics and Statistical Programming
• Manage key financial indicators (Revenue, Expenses, FTE, and DLU) according to corporate goals within Biostatistics and Statistical Programming functions
• Directs and mentors Biostatistical and Statistical Programming Management regarding activities involved in the design, analysis and interpretation of oncology clinical trials data conducted by SDC as well as leadership and management core expectations for each level
• Supervise and direct staff, both permanent and temporary, to include assignment of work, allocation of resources and management of timelines to ensure contractual obligations and objectives are met (ensure operational excellence; employee development, timelines, quality, problem solving and client service)
• Enhance and maintain organizational model within oncology to support corporate goals including client and therapeutically aligned models
• Serve as a consultant with internal and external cross-functional areas regarding Biostatistics
• Represent SDC in client meetings for capabilities and defense of proposals
• Ensure proposals accurately reflect services and algorithms to win new business and achieve project performance goals
• Function in the role as Senior Reviewing Statistician or Statistical Consultant on oncology clinical trial(s) as required
• Assess and adjust operational needs and requirements for oncology trials; ensure efficient allocation of resources and adequate staffing to meet goals and objectives of the department and company (including revenue forecasts, expenses, NI and DLU goals)
• Contribute to the development and enhancement of standard operating procedures for clinical trials; ensure that Biostatisticians and Statistical Programmers are adequately trained on and appropriately interpret and follow procedures
• Ensure compliance to all corporate and departmental standard operating procedures
• Represent Biostatistical and SAS Programming operations at regulatory meetings, sponsor meetings, and any other multifunctional meetings
• Adheres to all aspects of the SDC's Quality Management System
• Complies with SDC's data integrity & business ethics requirements
• Participates in cross functional decisions and policies as assigned

Requirements

• Successful record of accomplishment in establishing, directing and overseeing Biostatistical and Statistical Programming operations division/department with a focus on oncology
• Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
• Skilled in analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
• Excellent analytical skills, with the ability to process scientific and medical data in oncology trials
• Excellent knowledge of Biostatistics techniques commonly employed in oncology studies
• Capability of communicating technical concepts clearly, concisely, and understandably to nonstatistical colleagues
• Good leadership, organizational and time management skills
• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
• Strong interpersonal communication and presentation skills

Education or Equivalent Experience

• Master’s degree in biostatistics, statistics or other related, scientific field and at least eighteen years of relevant professional experience to include supervision and management experience; or an equivalent combination of relevant education and/or experience.

Benefits

What you can expect from us:

• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, and offer a flexible work schedule, engaging work culture, and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• We constantly grow and innovate to support our clients and employees' needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• With a proven track record, SDC has successfully executed client clinical programs since 2005.
• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short-Term & Long-Term Disability
• Training & Development
• Work From Home
• Profit based incentive