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 & 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.
Other Job Requirements:
Some domestic and international travel required.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.