Job Information
Cytel Principal Biostatistician FSP - RWE and Medical Affairs in Montgomery, Alabama
The role is responsible for statistical activities in support of Medical Affairs and analyzing RWD, including post approval value evidence generation, secondary publications, post marketing study design and study protocol development, analysis and reporting of observational or clinical study data, and other post hoc and exploratory analyses as needed.
Summary of Key Responsibilities
Leads statistical support for post approval value evidence generation and reimbursement submissions
Conducts post hoc analysis to support publications and presentations
Reviews and authors abstract, manuscript, regulatory documents
Collaborates with cross-functional team to support observational studies
Develops statistical sections of study protocols and statistical analysis plans.
Collaborates with Data Management and Medical Research on design of eCRFs
Provides statistical guidance on conduct of ongoing studies.
Accountable for the collaboration with Statistical Programming to implement statistical analysis of all clinical trial, registry, observational and non-interventional data supporting Medical Affairs needs
Contributes to observational study reports and regulatory documents, e.g., DSURs, briefing documents, etc.
Contributes to scientific articles, summarizing data collected in Alnylam studies.
Participates in other activities and meetings to support Biostatistics and the Medical Affairs team as needed
Qualifications
PhD in Biostatistics, Statistics, or equivalent with at least 3 years pharmaceutical biostatistics experience; or MS with at least 5 years’ relevant experience
Excellent written and oral communication and presentation skills
Strong knowledge of research methodology in HEOR (Health Economics and Outcomes Research) and pharmacoepidemiology
Ability to explain methodology and the consequences of decisions in lay terms
Significant, independent experience with statistical modeling of time-to-event outcomes (e.g., death, AE, hospitalization) including repeated or recurrent data and competing risk models
Advanced analytics techniques such as propensity score matching in analyzing RWD
Experience in survival analysis
Proficiency in SAS statistical procedures (e.g., PHREG, GENMOD, LOGISTIC, LIFETEST, MIXED)
Extensive experience programming in SAS
Extensive experiences working on data analysis with clinical studies database
Experience working on post-approval observational and clinical studies
Understanding of ICH GCP as well as general knowledge of industry practices and standards
Experiences in R programming language and other statistical software.
Experience with CDISC, including SDTM, ADaM, CDASH
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.