SAS Programmer II
Waltham, MA

Job Description

Company Overview

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com .

SAS Programmer II:

Alkermes is in an exciting phase of growth that few biotechnology companies achieve, with our diversified portfolio of commercial products and an exciting late-stage pipeline. We are moving ahead with global capabilities, an established approach to innovation, world-class manufacturing, financial strength, and our experienced and dedicated people. To achieve our goals for continued growth, the new position of SAS Programmer II was created in the Clinical Development team. This person will:

* Implement SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS.
* Design, develop, evaluate, validate and modify computer programs using SAS to analyze clinical data.
* Produce and deliver standard datasets, program edit checks and produce quality tables, figures and listings in a timely fashion and high quality.
* Use their thorough knowledge of CDISC theory and implementation guidelines to create and validate CDISC standard datasets with minimal instruction or input from the supervisor.
* Provide input in the design and development of clinical trial protocols, case report forms and clinical databases.
* Review eCRFs (Case Report Form) to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in the protocol.
* Annotate eCRFs and write SDTM programming specifications.
* Develop ADaM programming specifications in collaboration with biostatisticians and other clinical development colleagues.
* Work closely with clinical operations, data management and statisticians to generate and validates statistical output - tables/listing/figures.
* Liaise with vendors as needed to facilitate electronic data transfers and statistical programming.

Experience Requirements:

* Minimum Bachelor's degree with 4-6 years or Master's degree with 2-4 years equivalent level of experience in pharmaceutical/biotech, or CRO setting
* Good project management skills, CRO oversight skills, professional attitude, self improvement mentality with positive attitude
* Good written and oral presentation skills and ability to communicate effectively to other programmers and non-technical colleagues
* Ability to think creatively and independently, and to form sound opinions and make sensible decisions in a dynamic environment
* Extensive experience working with data management on data checking to ensure locked database in pristine quality
* R programming experience, a plus
* Strong knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
* Strong interpersonal, organizational, and multi-tasking skills
* Excellent attention to detail and problem solving skills
* Windows applications: Word, Excel, Powerpoint, etc.

Physical Demands and Work Environment:

Full time position in Waltham

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

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