Biostatistician (Associate Director)
Responsible for assisting the Director, Biostatistics with management and leadership of biostatistics-related activities within therapeutic area through direct product responsibility. Contributes to product development strategy and serves as a statistical expert in registration and communication activities. Represents Shire and provides input to his/her supervisor for statistical issues in communications with regulatory authorities. Reviews regulatory documents such as protocols and Clinical Study Reports, as well as summary documents.
Provides leadership in biometrics activities pertaining to study projects. Collaborates with project teams on design and analysis of clinical trials; selects appropriate statistical methods for design of clinical trials and the analysis of clinical study data; provides input into clinical development plans.
Provides specification and reviews draft randomization schedules. Primary SAP author. Determines and provides appropriate sample size calculations for specific objectives of study design.
Reviews statistical outputs. Primary author of the statistical methodology section(s) of study reports for study and integrated reports.
Responsible for interacting with regulatory authority personnel on clinical trial statistical issues in the design, analysis of clinical trials, design of other study types, and data presentations.
Reviews regulatory documents such as CSRs, as well as summary documents.
Consults with the Medical Writer and Physician on the interpretation of efficacy results.
Contributes to the publication plan. Reviews abstracts, posters, and manuscripts to support Medical Affairs.
Leads or contributes to departmental process improvement initiatives and development/revision of SOPs.
Contributes to the establishment and maintenance of common formats and templates for key Biometrics documentation (e.g., statistical section of protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures and Listings). Contributes to the design of standards for SAPs.
Directs outsourcing activities in collaboration with preferred vendors. Provides strategic and tactical input in the contracting with Global Biometrics preferred providers.
Education and Experience Requirements:
* M.S. in Biostatistics or closely related field is required.
* Ph.D. in Biostatistics or closely related field is strongly preferred.
* Generally has 8+ years of relevant pharmaceutical experience.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.
Please apply at: Application URL: http://www.aplitrak.com/?adid=YWxlYXRvbi4xNTQ1Ny4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ