Associate Director, Biostatistics

Function/Scope:



This position directs clinical trial biostatistics and programming activities for Clinical; works on abstract problems across functional areas of the business. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Interacts internally with executive level management; and externally with regulatory agencies and experts in the field as well as any contracted resource for biometrics.

Duties and Responsibilities Include But Are Not Limited To:

• Serves as functional leader within biostatistics; liaises frequently with product strategy teams and communicates plans and strategy to department and subordinates.
• Directs activities for selection of appropriate statistical methods for analysis of clinical study data; provides input into clinical development plans, approves all protocols, statistical analysis plans, and case report forms to ensure adequate control and design of studies.
• Accountable for the final statistical analysis plan for all studies conducted by company. Responsible for ad hoc reporting and meta-analyses.
• Responsible for interacting with FDA personnel on clinical trial statistical issues and data presentations.
• Reviews regulatory documents such as CSRs, as well as summary documents.
• Directs outsourcing activities in collaboration with preferred vendors. Provides strategic and tactical input in the contracting with Global Biometrics preferred providers.
• Consults with the Project Team Members on the interpretation of efficacy results.
• Contributes to the publication plan. Authors and reviews abstracts, posters, and manuscripts to support Medical Affairs.
• Key member of Submissions team
• May lead departmental process improvement initiatives and contribute to SOPs
• Contributes to the establishment and maintenance of common formats and templates for key Biometrics documentation (eg statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Contributes to the design of standards for SAPs.
• Identifies the need for contractors and supervises contractors to support projects.
• Responsible for hiring, planning and assigning work, setting objectives and development plans, appraising performance, giving performance related feedback and rewarding and recognizing employees.
• Performs other duties as required.

Desired Knowledge and Abilities:

• Strong background and working knowledge of statistical methods that applies to all phases of clinical trials.
• Must have a working knowledge of statistical analysis plans including the report outline, mockup tables, graphs and data listing shells and appendices.
• Must have a working knowledge of all appropriate relevant regulatory guidance (e.g. ICH, FDA and EMEA).
• Direct submission/filing experience is preferred. Submission experience outside of the US is an asset.
• Proficiency in SAS and nQuery software packages. Knowledge of CDISC requirements
• Ability to program if needed, oversees programming work performed by staff or vendors.
• Ability to determine appropriate designs and analyses for clinical trials.
• Ability to respond to regulator's inquiries for products undergoing registration and approved products.
• Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed
• Ability to help others understand the broader business and organizational context (inspiring and motivating others)
• Demonstrated ability to deliver excellence by integrating planning efforts across departments or organizational boundaries to ensure organizational effectiveness (delivering excellence)
• Demonstrated ability to reinforce a culture in which partnering is a norm
• Demonstrated ability to accept responsibility for individual and team performance
• Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making)
• Requires strong organizational, presentation, documentation and interpersonal skills as well as a willingness to work within a team-oriented environment
• Must be able to travel up to 20% of time on average, may be higher in accordance with company and/or project requirements.
• Computer skill should include proficiency with Microsoft Office suite of software.

Education and Experience:

• MS or Ph.D. in Statistics/Biostatistics or closely related field (oncology experience preferred).
• Minimum 3-5 years' industry experience in clinical/medical research, but generally has 5-8 years of highly relevant experience.