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Biostatistics

Company: Gan & Lee Pharmaceuticals
Location: Bridgewater
Posted on: January 15, 2022

Job Description:

Summary

This position is responsible for providing statistical input to development strategies, and ensuring effective implementation, in order to support product development objectives within one or more therapeutic areas. This position is responsible for all biostatistical activities of Gan &Lee projects that are correctly designed, properly analyzed, and clearly presented to support new product development, domestic and international regulatory submissions, and the maintenance and growth of existing products. This individual reports to the head of Clinical Sciences.

Education and Credentials
PhD in Biostatistics/Statistics (preferred) or MS in Biostatistics/Statistics

Experience

The position will be filled at a level commensurate with experience.
Director - Ph.D. with 8-10 years of relevant experience preferred or MS with 12+ years of relevant
Senior Director - Ph.D. with 12-15 years of relevant experience

Skills And Qualifications
Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
Ability to provide technical solutions to a wide range of difficult problems. Solutions are innovative, thorough and practicable, and consistent with objectives.
Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional.
Proficient in SAS or R programming preferred, and detailed knowledge of SAS procedures as well as computing tools for modelling and simulations.
Working knowledge of regulatory guidelines and Commercial needs relating to statistical analysis, study reports and statistical components of regulatory submissions.
Experience in representing the company and communicating with health authorities for biostatistical approach
Able to manage multiple projects simultaneously, to manage and coordinates limited resources to produce quality deliverables within timelines for competing priorities, and to be flexible when priorities change.
Highly effective written, oral, and interpersonal communication skills as well as ability to work in interdisciplinary contexts outside statistics. Demonstrates leadership skills with effective communication including being able to explain methodology and consequences of decisions in lay terms; able to translate requests to meaningful and relevant hypotheses/statistical questions
Experience and/or capability of building and leading a statistical team including biostatistics and statistical programming

Responsibilities
Contributes to the development of study protocols, in particular, the statistical sections (e.g., sample size calculations, statistical methodology and analyses).
Develops statistical analysis plans and file/report specifications; determine appropriate statistical methodology for data analysis; reviews study setup activities including but not limited to randomization, CRFs and data edits.
Performs statistical analyses, interprets statistical results, and assists in clinical study reports including integrated summaries for submissions.
Ensures quality of deliverables by internal programming team and/or external vendors through appropriate validation and review for completeness and accuracy.
Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.
Contributes to development of submissions to worldwide regulatory agencies and preparation of responses to statistical issues arising in regulatory activities or from external development partners.
Maintains liaison with clinical research personnel in order to identify and provide the statistical support required by the development strategy under the direction of the clinical leader.
Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Clinical Development Head.
Provides critical input to the team in optimizing study or trial designs in line with study or trial objectives and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.
Participate and representing the company in communicating with health authorities for biostatistical approach
Leading the development of a biostatistical group to accommodate the long-term company growth
Provides guidance and management to statisticians and programmers to ensure high quality and timely deliverables.
Contributes to the long-term growth strategy of the department by participating in process improvement initiatives, keeping abreast of the current statistical methodology development, and providing mentorship to new/junior biostatisticians.

Summary

The Director Director of Biostatistics is responsible for providing statistical input to development strategies, and the formulation of effective implementation plans to support product development objectives within one or more therapeutic areas. The Director/Senior Director is responsible for the activities of Biostatistics to ensure that Gan &Lee projects are correctly designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions and the maintenance and growth of existing products. This individual reports to the head of Clinical Sciences.

Education and Credentials PhD in Biostatistics/Statistics (preferred) or MS in Biostatistics/Statistics
Experience

Position will be filled at level commensurate with experience. Director - PhD with 8-10 years of relevant experience preferred or MS with 12+ years of relevant
Senior Director - PhD with 12-15 years of relevant experience
Skills and Qualifications
Thorough understanding of statistical principles and clinical trial methodology with the ability to practice and implement them.
Ability to provide technical solutions to a wide range of difficult problems. Solutions are innovative, thorough and practicable, and consistent with objectives.
Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional.
Proficient in SAS or R programming preferred, and detailed knowledge of SAS procedures as well as computing tools for modelling and simulations.
Working knowledge of regulatory guidelines and Commercial needs relating to statistical analysis, study reports and statistical components of regulatory submissions.
Experience in representing the company and communicating with health authorities for biostatistical approach
Able to manage multiple projects simultaneously, to manage and coordinates limited resources to produce quality deliverables within timelines for competing priorities, and to be flexible when priorities change.
Highly effective written, oral, and interpersonal communication skills as well as ability to work in interdisciplinary contexts outside statistics. Demonstrates leadership skills with effective communication including being able to explain methodology and consequences of decisions in lay terms; able to translate requests to meaningful and relevant hypotheses/statistical questions
Experience and/or capability of building and leading a statistical team including biostatistics and statistical programming
Responsibilities
Contributes to the development of study protocols, in particular, the statistical sections (e.g., sample size calculations, statistical methodology and analyses).
Develops statistical analysis plans and file/report specifications; determine appropriate statistical methodology for data analysis; reviews study setup activities including but not limited to randomization, CRFs and data edits.
Performs statistical analyses, interprets statistical results, and assists in clinical study reports including integrated summaries for submissions.
Ensures quality of deliverables by internal programming team and/or external vendors through appropriate validation and review for completeness and accuracy.
Ensures that documents, specifications, programs, and macros are consistent and comply with project and company standards. Follows best practices for Data Integrity.
Contributes to development of submissions to worldwide regulatory agencies and preparation of responses to statistical issues arising in regulatory activities or from external development partners.
Maintains liaison with clinical research personnel in order to identify and provide the statistical support required by the development strategy under the direction of the clinical leader.
Contributes high quality and timely deliverables as assessed by stakeholders such as the project team, the clinical trial team, and the Clinical Development Head.
Provides critical input to the team in optimizing study or trial designs in line with study or trial objectives and supports scenario simulations and sample size calculations based on relevant technical and disease/scientific/functional area knowledge.
Participate and represent the company in communicating with health authorities for a biostatistical approach
Leading the development of a biostatistical group to accommodate the long-term company growth
Provides guidance and management to statisticians and programmers to ensure high quality and timely deliverables.
Contributes to the long-term growth strategy of the department by participating in process improvement initiatives, keeping abreast of the current statistical methodology development, and providing mentorship to new/junior biostatisticians.

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Keywords: Gan & Lee Pharmaceuticals, Trenton , Biostatistics, Other , Bridgewater, New Jersey

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