Our client is a development-stage biopharma developing first-in-class therapies for the treatment of Diabetes. They are seeking an experienced Senior Biostatistician to manage and support Biostatistics deliverables for multiple clinical studies. In this role you will be accountable for all statistical aspects of clinical studies and submissions as well as developing collaborative cross-functional relationships both internally and externally. This is an expanding group; several of their lead compounds will be entering the submission stage and this person will play a key in the NDA submission process.
In this role, you will:
Develop and review of content for statistical analysis plans and statistical sections of protocols in coordination with designated internal and external scientific leadersReview and recommend options for trial designParticipate as the lead statistical expert on project teams for assigned studiesResponsible for all statistical aspects of assigned clinical studiesReview protocols, case report forms, data management plans, sample size estimates, randomization schedules, clinical study reports and sections of regulatory submissionsValidate or produce analyses in support of CSRs and other regulatory submission needsWork closely with internal and external statistical and programming resources; resolve statistical programming issues related to interpretation of the SAPLead interactions with external vendors such as CROs and statistical consultants for assigned studiesDevelop and review Biostatistics policies, standard operating procedures and other controlled documentsDevelop collaborative relationships with site personnel, colleagues and vendorsParticipate in corporate and departmental meetings
Desired for this role:
Master's or Ph.D. in Statistics, Statistical Science, Biostatistics, Data Science or similar fieldAt least 5 years of experience as a Biostatistician focused on clinical trialsStrong hands-on programming skills for clinical trial reporting (SAS preferred)Attention to detail, accuracy, initiative, excellent written and oral communication skills and scientific curiosity are essentialAbility to juggle several complex projects simultaneouslyAbility to adjust quickly based on company needsExcellent analytical and problem-solving skillsAbility to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environmentStrong organizational, time management, and collaborative skills with the ability to handle multiple assignments effectively and deal with ad hoc requestsMust be able to work cooperatively with internal functional group stakeholders, as well as cross-functional partners