Principal/Senior Principal Biostatistician

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 apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. 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.

#LI-Remote

Primary Responsibilities

• Serve as an internal consultant for biostatistics analysis tools and methods
• Serve as a 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 assigned clinical study budgets for biostatistics analysis support
• Develop, coach and mentor junior biostatistics department personnel
• Act as the lead statistician on clinical research projects and help with SAS programming
• 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/review 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
• Manage biostatistics timelines, budgets, and client expectations

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 and clients
• 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
• Focus on quali