Manager, Biostatistics

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.  

Minimum qualification:

Master’s degree and 8+ years of relevant work experience, including 1 - 2 years in leadership capacity; PhD and 2 - 5 years of relevant work experience, including 1 - 2 years in leadership capacity

Level-specific responsibilities:

• Performs statistical analyses for clinical studies. Develops and reviews statistical analysis plans (SAP) and tables, listings, and figures (TLF).
• Reviews protocols to ensure statistical integrity and optimal study design. Writes statistical sections of study protocol.
• Supports creation, maintenance, and adherence to client specific standards through identifying key variables, definitions statistical methods and data structures.
• Leads the biostatistics deliverables teams. Interacts with clients as key statistical contact.
• Trains and coordinates statisticians within a project or set of studies. May mentor junior statisticians.
• Manages resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations.
• Participates in business development activities by preparing Request for Proposal and effort estimation.

Knowledge, skills and abilities:

• Good knowledge of statistical methods for design of clinical studies and analysis of clinical data
• Good understanding of ICH guidelines and relevant regulatory requirements
• Good knowledge of SAS programming best practices and regulations
• Good knowledge of company people management policies and procedures, including hiring, performance management, corrective action, and compensation administration
• Good people management and mentoring skills including coaching, conflict resolution, interviewing, and providing feedback and recognition
• Excellent oral and written communication skills including ability to negotiate
• Good quality-oriented analytical skills
• Excellent attention to detail
• Ability to communicate complex business concepts to a multi-disciplinary audience

Ability to manage team resources to ensure attainment of departmental objectives 

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy,  gender identity or gender expression), sexual orientation,  parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.