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Description
The Neurology Business Group at Eisai is seeking a qualified candidate to fill the position of Manager, Statistical Programming. In this capacity, the incumbent will be primarily responsible for SAS programming activities supporting multiple studies (Phase I) for a single or multiple compounds within related therapeutic areas. Programming experience from inception through submission in related areas such as epilepsy, neurodegenerative disease, Alzheimer Disease, sleep disorders, cardio vascular and inflammatory disease is preferred.

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.

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.

Qualifications

The ideal candidate will have in-depth experience as a statistical programmer within the clinical development function of a therapeutic area(s). This individual must have the ability to effectively follow instructions and to work under supervision.

Functioning primarily as an individual contributor, it is also expected that he/she will at times work with vendors and therefore must have good communication skills.

An advanced education culminating in an MS degree with a minimum of 4 years proven pharma industry experience in clinical development statistical programming methods & processes is required.

Experience with CDISC (SDTM/ADaM) is also required



* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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