Social Icons

Thứ Bảy, 28 tháng 2, 2015

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

@ a< href="http://sap.rssfeeds.pw">Sap RSS News





Subribe Sap Feeds










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

» Apply Now


Indeed will send your application to careers@celldex.com.


Please review all application instructions before applying.








» Apply Now


Indeed will send your application to careers@celldex.com.


Please review all application instructions before applying.








Không có nhận xét nào:

Đăng nhận xét

 

Sample text

Sample Text

Sample Text