Sr Manager, Biostatistics

The primary role of this position is to support planned and ongoing clinical programs in conjunction with other team members through creation of clinical development strategy; study design including analysis methodology and sample size calculation; writing statistical analysis plans and reviewing table and listing shells; reviewing protocols; reviewing tables, listings and figures; and providing input into clinical study reports, integrated summaries of efficacy and safety, and regulatory submission documents. Specifically, the successful candidate will be expected to:

• Develop and support strategies to advance new products for regulatory approval and commercialization including go/no go decisions and submission strategies, and to expand indications for existing products, in partnership with clinical development teams
• Collaborate with non-statisticians (project management, data management, statistical programming, regulatory, medical affairs, and pharmacovigilance/drug safety) to incorporate innovative, efficient and effective development strategies, proposing and implementing the most effective strategy for each situation
• Lead vendor selection and oversight for biostatistics, statistical programming, and interactive response technology (IxRS) services on assigned projects; manage and oversee biostatistics and statistical programming tasks performed by the vendor
• Provide statistical input on regulatory submissions (requests from agencies, meeting requests, NDA/BLA/MAA and other activities) and review input from other functional areas to ensure alignment
• Support risk-based monitoring plans and activities
• Ensure timeliness and quality of deliverables
• Travel as needed to execute assigned responsibilities and tasks

Required Qualifications, Skills and Education:

• PhD in statistics or related field and at least 3 years of industry experience preferred; MS in statistics or related field and at least 6 years of industry experience considered
• Professional, proactive demeanor
• Excellent written and verbal communication skills
• Excellent interpersonal and project management skills
• Comprehensive knowledge of clinical trials methodology and regulatory requirements, including experience with registration-enabling clinical trials, and demonstrated ability to contribute strategically
• Experience collaborating effectively with internal and external study management teams to meet project timelines
• Experience overseeing remote vendors with successful delivery of quality results on agreed timelines
• Experience implementing novel and innovative solutions to study design and analysis (e.g., Bayesian design and analysis, adaptive design, predictive probability of success or others), and ability to educate study team members in appropriate interpretation of study designs and results
• Computer skills: Proficient in Microsoft Office and SAS
• Knowledge of CDISC standards

Physical Demands (additions as needed):

• Ability to sit and stand for extended periods of time
• Ability to carry, handle and reach for objects
• Manual dexterity to operate office equipment, e.g. computer, phones, etc.