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Thứ Bảy, 28 tháng 2, 2015

Senior Manager/Associate Director, Statistician - Celldex Therapeutics, Inc. - Hampton, NJ

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Senior Manager/Associate Director, Statistician (Hampton, NJ)


Overview:


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.




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