Celldex Therapeutics seeks an experienced biostatistician to join our company as Senior Manager/Associate Director, Statistician. This position will be based on-site in our Hampton, NJ office.
Responsibilities and Duties:
Provide statistical expertise in design, analysis, and clinical report for phase I, II, III oncology clinical trials.
Represent the biostatistics function in the clinical development team and interact with other function team members.
Perform sample size calculation for continuous, dichotomous, and time to event endpoints in various study designs.
Write the statistical section in protocol and prepare the statistical analysis plan (SAP).
Lead internal biostatistics and programing team and provide statistical inputs to support the clinical study report for multiple clinical trials including planning, supervising, validating, and reviewing the statistical deliverables.
Perform simulation studies to explore the statistical operating characteristics in study design phase including innovative/adaptive designs.
Perform consistent statistical analyses to support publications in medical conferences.
Review protocol, CRF, IVRS Specs, SAP, SDTM Specs, ADaM Specs, CSR, conference presentation, manuscript for publication, and other statistical documents.
Participate in BLA/NDA submission activities as a key stat team member.
Oversee and manage CRO statistical and programming activities.
Contribute to the development of standard statistical documents including TLFs, SAP, Programming (ADaM) specs, SAS macros, and SOPs.
Requirements:
Knowledge of FDA, EMA, and ICH guidance for drug development.
Familiar with SDTM, ADaM, eSUB standards and requirements for regulatory submissions and CSR.
Familiar with the concept of study designs including group sequential design, dose-escalation designs, Simon’s 2-stage design, confidence interval design, interim futility/superiority analysis, multiplicity adjustment, and conditional power.
Familiar with statistical concepts including survival analysis (e.g. Log-rank test, Wilcoxon test, Cox regression model, counting process), categorical data analysis (e.g. CMH test, Fisher’s exact test), ANOVA/ANCOVA, longitudinal data analysis, generalized linear model, mixed model, missing data, and statistical modeling diagnostics.
Demonstrated ability to handle multiple priorities with timelines.
Experience leading effective teams and motivating team members.
Collaborate with other functions to resolve issues and improve efficiency.
Excellent presentation skills to interpret statistical concepts and results to clinical development team.
Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators.
Familiar with statistical software SAS and R.
Experience with regulatory submissions to support integrated summary of Safety (ISS) / Efficacy (ISE) preferred.
Experience/Knowledge with adaptive/innovative study designs preferred.
Experience with drug development in biologics and targeted therapies preferred.
Education/Experience:
Completed PhD in Statistics or related field required.
4 or more years of biopharmaceutical experience as a lead statistician required.
2 or more years of oncology experience preferred.
Experience as a lead biostatistician handling Phase IIb/III clinical trials required.
Qualified candidates interested in applying for positions at Celldex should submit a resume and cover letter, identifying the specific position to careers@celldex.com . Celldex will make every effort to respond to inquiries from qualified applicants who have the skills and interests we are seeking. We will not be able to respond to recruiting & placement firms who contact us in an unsolicited manner, nor to unqualified applicants. Celldex is an equal opportunity employer dedicated to diversity in the workplace.
Celldex , Inc. - 21 hours ago- save job -original job
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» Apply Now
Indeed will send your application to careers@celldex.com.
Please review all application instructions before applying.
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