Sr Mgr, Biostatistics 8/26/2016

Eisai Woodcliff Lake, NJ

Company
Eisai
Job Classification
Full Time
Company Ref #
3824BR
AJE Ref #
575983840
Location
Woodcliff Lake, NJ
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Doctoral Degree

JOB DESCRIPTION

APPLY
Department Name
Biostatistics Neuro

Location/Territory Name
Woodcliff Lake, NJ

Job Description
The Senior Manager, Biostatistics - Neuroscience will be expected to work independently with minimal supervision, serving as study statistician for clinical studies. The study statistician will be accountable for supporting protocol development and study initiation, developing SAP, TLG shells, specification of variable derivation, SQS plan and DMC charter, providing statistical and validation support for analysis datasets, statistical TLGs, performing and validating statistical analysis, independently reviewing CSRs and performing data interpretation, supporting preparation of inputs for regulatory documents, drafting responses to health authorities including execution of new analysis required for responses, and managing CROs. The immediate need is to support Phase II and III studies within the Neurology Business Group.

Scope and Responsibilities:

- Sets objectives, delivers results and implements policies and operational targets that have a direct impact on the work unit or operational outcome.
- Work may include policy changes or recommendations.
- Individual contributor with specialized knowledge.
- Has an easily discernible impact on the job area and expected results.
- Typically no cost center budget management responsibility.

Communication:

- Presents concepts, facts, and reports to mid-level internal and external clients to advise of key trends and issues.
- Contact with clients and external vendors and troubleshooting routine client inquiries. May represent the organization as a prime contact for technical matters of significant complexity.

- Develops SAPs, TLG shells and specifications of variable derivation
- Monitoring (Not Applicable for Phase I (Clinical Pharmacology) statistician)
* Develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues to ensure high quality study data
* Develops the Data Monitoring Committee charter in collaboration with other functions and liaises with independent statisticians.

Clinical Study Report
* Provides statistical and validation support for analysis datasets, statistical tables, figures and listings
* Performs and validates statistical analysis
* Independently reviews CSRs and performs data interpretation.

* Supports preparation of inputs for regulatory documents and helps to prepare for meetings with health authorities
* Drafts responses to health authorities including execution of new analysis required for responses.

* Enhances the capabilities of current resources (tools, systems, vendors, etc.), technologies, and processes for the team
* May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines.

* Resolves expense issues and manages costs of work teams before issues arise
* Manages team finances in compliance with financial standards and guidelines
* Assists the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalate issues when appropriate.

* Manages individual contributors
- Manages all employee-related activities throughout the year, including performance management and development
- Identifies and communicates the skills, behaviors and experiences required to develop employees
- Sets goals, reviews performance and provides feedback on a regular basis.
* Assists or Leads training of junior staff

III. Qualifications and Experience

PhD strongly preferred, but combination of education and experience may be considered in lieu of PhD

Experience in clinical development biostatistics methods and processes in industry setting required

Functional Technical Competency in the following:

Clinical Development
Plan Creation
Statistical
Analysis
Statistical Programming
Regulatory Process for Biostatistics
Business Knowledge
Therapeutic Area Knowledge
Regulatory Knowledge
Project and Resource Management
Compliance

Job Qualifications
III. Qualifications and Experience

PhD strongly preferred, but combination of education and experience may be considered in lieu of PhD

Core Experiences

Experience in clinical development biostatistics methods and processes in industry setting required

IV. Competencies

Functional Technical Competency in the following:

Clinical Development
Plan Creation
Statistical
Analysis
Statistical Programming
Regulatory Process for Biostatistics
Business Knowledge
Therapeutic Area Knowledge
Regulatory Knowledge
Project and Resource Management
Compliance

Auto req ID
3824BR

Job Type
Full-time



Eisai is an Equal Opportunity Employer Minority / Female / Disability / Vet