Job Description

SDC is a collection of diversified professionals who are committed to providing experienced teams who will take ownership of client needs and are positively engaged in projects. We provide top-tier clinical trial services to pharmaceutical, biotechnology, and medical device/diagnostic companies since 2005. Our global team operates in the highest quality of ethics and sustainability by adopting our clients' needs as our own and delivering exceptional results. We view ourselves as a valued partners to our clients and our proven track record of success has allowed us to grow year over year.

Our commitment to our clients is the same commitment to our employees. By offering strong benefits, focused career development, and a flexible schedule we can attract and employ some of the most talented people in the industry. Energy, Integrity, Engagement, Innovation, Ownership, and Commitment are our core values and the backbone of our culture at SDC.

Take a look at how you can join our team!

Working with the director, oversee and manage all operational aspects of the biostatistics department. Apply a high level of managerial and technical expertise to help lead and develop the biostatistics staff. Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department. Maintain the statistical and analytical integrity of clinical trials analyzed by SDC. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning.

Primary Responsibilities

• Oversee day-to-day project, developmental, and consulting biostatistics analysis processes and results
• Serve as subject matter expert during client and vendor meetings for biostatistics analysis support
• Actively support business development in capabilities presentations to prospective and current clients
• Effectively manage department and clinical study budgets for biostatistics analysis support
• Develop, coach and mentor biostatistics department personnel
• Act as the lead statistician on clinical research projects and help with SAS programming, as required
• Provide statistical expertise for study design of clinical trial protocols
• Write statistical methods section of the study protocol, as needed
• Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
• Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
• Program summary tables, data listings and graphical representations of clinical trials data
• Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
• Prepare key sections of clinical study reports and various regulatory documents
• Perform statistical QC of all department outputs including analyses and clinical study reports
• Provide statistical support to answer questions from external clients (such as FDA, Investigators)
• Contribute to the development, maintenance, and training of standard operating procedures (SOPs)
• Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
• Adhere to all aspects of the Statistics & Data Corporation's quality system
• Comply with Statistics & Data Corporation's data integrity & business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Requirements

• Effective leadership, budget forecast, and implementation skills
• Excellent analytical skills, with the ability to process scientific and medical data
• Able to work independently and in teams
• Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating, and resource management skills
• Excellent knowledge of statistical programming
• Expertise in manipulating and analyzing SAS data
• Able to identify data issues, present problems, and implement solutions.
• Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
• Excellent organizational and time management skills, with the ability to multi-task
• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
• Strong interpersonal communication and presentation skills
• Able to effectively collaborate across cross-functional teams

Education or Equivalent Experience

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