Associate Director to Director, Biostatistics
Location: Philadelphia, PA

Contributes to product development strategy and serves as a statistical expert in registration and communication activities. Represents the company for statistical issues in communications with regulatory authorities. Reviews and approves regulatory documents such as CSRs, as well as summary documents. Supports due diligence activities.

Provides leadership in biometrics activities pertaining to study projects. Serves as statistical expert on Product Strategy Teams. Provides input into CDPs and individual study design. Provides specification and reviews draft randomization schedules. Reviews SAP. Provides the statistical analyses. Reviews statistical outputs. Reviews the statistical methodology sections(s) of study reports for study and integrated summary reports. Provides input into product labeling. Consults with the Medical Writer and Physician on the interpretation of efficacy results. Reviews CRFs. Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs.

Responsibilities may include interviewing, hiring and training employees: planning, assigning, and directing work; setting objectives; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Identifies the need for contractors and supervises contractors to support projects. Leads in providing statistical training to Global Biometrics and other Research and Development staff.

• M.S. in Biostatistics or closely related field is required.
• Ph.D. in Biostatistics or closely related field is strongly preferred.
• +/- 10 years of relevant pharmaceutical development experience.

Provides input to the VP of Global Biometrics on SOPs in order to meet current regulatory needs. Follows all relevant SOPs and working practices. Leads in and 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). Leads in the design of standards for SAPs.

Supports Global Medical Affairs through consultation and review of abstracts, manuscripts and posters.

Communicates and interacts with the staff from various departments of the company and from CRO partners, consultants and academics concerning proper statistical methods. Leads in providing strategic and tactical input in the contracting with Global Biometrics preferred providers.

• Strong background and working knowledge of statistical methods that apply 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 strong working knowledge of all appropriate relevant regulatory guidances (e.g. ICH, FDA and EMEA).
• Strong attention to detail and accuracy.
• Ability to read, analyze and interpret complex technical documents.
• Ability to communicate complex issues in oral and written form.
• Ability to establish priorities and meet deadlines.
• Must be able to work in a fast paced environment with demonstrated ability to prioritize multiple competing tasks and demands.
• Ability to work independently, take initiative and complete tasks to deadlines with quality.
• Demonstrated ability to work in a team environment.
• Ability to communicate effectively upwards, downwards, and laterally throughout the organization

Ability to determine appropriate designs and analyses for clinical trials.

Ability to respond to regulator's inquiries during review cycle and on an ad hoc basis for products undergoing registration and approved products.

Ability to provide input into decision-making process for due diligence exercise.

Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed.

Proficiency in SAS and nQuery software packages.

Some international travel required.

Domestic travel on project needs basis