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Director of Biostatistics

Job Description

Director of Biostatistics is needed for a direct hire opportunity for Yoh Scientific's client located in the Woodcliff Lake, New Jersey area. This position is with a major pharmaceutical company and with a Bachelors degree or higher are encouraged to apply. There are two openings. Please send your Word copy of your resume to [Click Here to Email Your Resumé].

This position serves a critical role within the clinical development in that he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis datasets and coauthoring manuscripts. In addition, this position would work with statisticians on process development, internal contractor oversight, and various team management and development tasks.

Essential Functions

  • Reviews protocols and other study documents that are developed in collaborations of business alliances. Leads and oversees interactions with respect to statistical discussions. Provides statistical supports for regulatory submissions in the collaborations.
  • Provides statistical supports for clinical trials and drug development plans within the clinical development. Works with the clinical, project management, and data manager teams on strategic designs of studies; develops, reviews and/or approves study documents such as clinical study protocols, statistical analysis plan, CRF, edit check specification, data management plan, final database validations, final study report. Performs statistical analyses.
  • Influences the proper use of statistics throughout Eisais oncology business group; contributes to the development of departmental standards and guidelines.
  • Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs.
  • Functions as lead statistician in global registration trials and manages all related statistical activities.
  • Leads and oversees preparations of inputs for regulatory documents and meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses.
  • Comprehensively assesses options and analytical strategies and identify team training needs and recommends solutions
  • Provides strategic input and supports exploration of methods to improve Biostatistics operational efficiency

Job Qualifications

  • PhD with 10+ years or MS with 15+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment.
  • Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process.
  • Experience with CRO oversight and FDA submission preferred.
  • Excellent technical writing and verbal communication skills.
  • Strong teamwork ability/commitment and individual initiative.
  • Strong organizational skills with ability to effectively manage multiple studies.
  • Excellent programming skills in SAS or R.
  • MUST HAVES: Completed MS or PhD, strong employee management skills and strong statistical technical skills.

CB1

Job Requirements

 

Job Snapshot

Location US-NJ-Woodcliff Lake
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Pharmaceutical
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Company Overview

Yoh

Yoh is here. Yoh is there. Yoh is virtually everywhere. All in and busy going all out, doing everything it takes to take you where you want to go – forward. How? By foregoing the talent pool in favor of our own sea of talent, helping you find just the right person for the job. And if you think you're that person, we want to talk to you. Learn More

Contact Information

US-NJ-Woodcliff Lake
Yoh
Snapshot
Yoh
Company:
US-NJ-Woodcliff Lake
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Pharmaceutical
Store Type:

Job Description

Director of Biostatistics is needed for a direct hire opportunity for Yoh Scientific's client located in the Woodcliff Lake, New Jersey area. This position is with a major pharmaceutical company and with a Bachelors degree or higher are encouraged to apply. There are two openings. Please send your Word copy of your resume to [Click Here to Email Your Resumé].

This position serves a critical role within the clinical development in that he/she will be responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis datasets and coauthoring manuscripts. In addition, this position would work with statisticians on process development, internal contractor oversight, and various team management and development tasks.

Essential Functions

  • Reviews protocols and other study documents that are developed in collaborations of business alliances. Leads and oversees interactions with respect to statistical discussions. Provides statistical supports for regulatory submissions in the collaborations.
  • Provides statistical supports for clinical trials and drug development plans within the clinical development. Works with the clinical, project management, and data manager teams on strategic designs of studies; develops, reviews and/or approves study documents such as clinical study protocols, statistical analysis plan, CRF, edit check specification, data management plan, final database validations, final study report. Performs statistical analyses.
  • Influences the proper use of statistics throughout Eisais oncology business group; contributes to the development of departmental standards and guidelines.
  • Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs.
  • Functions as lead statistician in global registration trials and manages all related statistical activities.
  • Leads and oversees preparations of inputs for regulatory documents and meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses.
  • Comprehensively assesses options and analytical strategies and identify team training needs and recommends solutions
  • Provides strategic input and supports exploration of methods to improve Biostatistics operational efficiency

Job Qualifications

  • PhD with 10+ years or MS with 15+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment.
  • Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process.
  • Experience with CRO oversight and FDA submission preferred.
  • Excellent technical writing and verbal communication skills.
  • Strong teamwork ability/commitment and individual initiative.
  • Strong organizational skills with ability to effectively manage multiple studies.
  • Excellent programming skills in SAS or R.
  • MUST HAVES: Completed MS or PhD, strong employee management skills and strong statistical technical skills.

CB1

Job Requirements

 
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