August 11, 2016

Mgr, Statistical Programming

Eisai - Woodcliff Lake, NJ

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  • Company
    Eisai Eisai
  • Location
    Woodcliff Lake, NJ
  • Job Type
  • Job Classification
    Full Time
  • Experience
    Entry Level (0 - 2 years)
  • Education
    Bachelors Degree
  • Company Ref #
  • AJE Ref #

Job Description

Department Name
Statistical Programming

Location/Territory Name
Woodcliff Lake, NJ

Job Description
- 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.
- Executes work procedures in a project context. Consistently exercises judgment and discretion within generally defined procedures.
- Technical expert with sufficient expertise and experience to be considered for sensitive or complex assignments.
- Called upon to develop solutions utilizing creativity and ingenuity.
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.
- Directs the activity of a work team project within the department. May have responsibility for management of highly skilled professional employees.
- Work is completed under limited supervision.
- Typically reports to an Associate Director or above.
- Reviews SAP, TLG shells and variable derivation rules and provides feedback.
- Reviews Study Quality Surveillance Plan and Data Monitoring Committee charter.
- Implements the monitoring plan set by the statistician and produces the needed datasets and TLGs.
- Reviews the SAP, provides feedback to the statistician and develops (with the statistician) study specific datasets.
- Develops programs for the creation and validation of datasets (SDTM & ADaM) and TLGs.
- Integrates multiple studies in support of an ISS/ ISE.
- Supports ad-hoc, interim, exploratory, publications and performs programming and generates outputs.
- Maintains data, programs and reports in accordance with 21 CFR part 11.
- Creates / validates the eSubmission components (transport datasets for both SDTM & ADaM, Annotated CRF, define documents)
- Makes recommendations for improving resources (tools, systems, vendors, etc.) needed by the team.
- Manages the workflow of others to ensure work is done within a given deadline.
- May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines.
- Tracks the expenses of work teams to anticipate cost issues.
- Manages the use of financial standards, guidelines and compliance for more informed and empowered decisions.
- May assist the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalates issues when appropriate.
- Provides feedback, sets clear tasks and objectives and coaches team members on a periodic basis.
- May support employees by providing input into recruitment, selection, performance, succession, and transition activities.
- Trains team members on processes and / or systems.
PEOPLE MANAGEMENT(if assigned direct reports)
- 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.

Job Qualifications
- BS or MS in Relevant Field
- Experience in clinical development statistical programming methods and processes in industry setting required.
- Foundational proficiency in statistical analysis.
- Intermediate proficiency in statistical programming.
- Foundational proficiency in regulatory process for biostatistics.
- Foundational proficiency in business knowledge.
- Foundational proficiency in therapeutic area knowledge.
- Foundational proficiency in regulatory knowledge.
- Foundational proficiency in project and resource management.
- Must be able to problem solve - plan - make timely decisions - delegate - set priorities - manage conflicts - possess interpersonal savvy - composure - and presentation skills.

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Job Type

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