Associate Director, Clinical Programming at Eisai

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.  If this is your profile, we want to hear from you.

The Associate Director, Clinical Programming must have expertise in addressing technical challenges in the programming area that connect JReview, SAS, EDC, and CDISC standards. The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate complete programming solution in the above area. The individual will be responsible for implementing new technological solutions for end users.

The Associate Director, Clinical Programming manages and oversees JReview and SAS program development for clinical data processing, data review reports and listings. This includes but is not limited to: Program design and development, standard program libraries development and maintenance. Ensures programming related technical and end user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of Clinical Programming will oversee the Data Review programming and JReview within IODS. Reporting to the Assoc. Director of Clinical Programming is the senior level highly technical SAS and JReview programmers.

Responsibilities Include but are not limited to:

• Manage, coordinate, provide programming strategy in designing and developing programs in Eisai Clinical Computing Environment
•  Implementation of new programs, enhancements & support of Eisai Clinical Computing Environment
•  Support study migration, program validation, technical documentation
• Manage J-Review set up, J-Review user access management, training, programming support & upgrades                                       
• Manage automated process for converting clinical data to standard normalized datasets which are used for downstream programming  
• Manage development and upgrade of standard Reports for data review & cleaning          
• Manage standard tools development & enhancement related to clinical data processing
• Automation of the essential Reports                                            
• Manage the programming for Laboratory data management, conversion, normal ranges, & reconciliation
• Manage Development & maintenance of standard programs for metric reports, EDC user access reports that are use across all oncology studies by management.
• Develop/maintain Oncology standard macro library, standard listings, and reports.
• Proactively identify and track Oncology clinical area need in terms of program development and propose/implement solutions.

Requirements

• Bachelor’s degree in computer science or related field required.
• Must have 10 or more years of relevant programming and application development experience, 5 or more years project management & people management experience
• Experienced in working in Medidata EDC platform.
• Experienced in SDTM
• Leadership skills and experience are required.
• Experience with programming methodologies, best practices, software applications development/support in the pharmaceutical or related industries, and system validation methodologies.
• Excellent technical skills in SAS system, JReview and application development.
• Provide technical guidance to the programming team in terms of application design, development, validation
• Good understanding in Clinical Data Management Systems & standards, e.g., InForm, relational Databases, Oracle, SQL, CDISC, and CDASH.
• Familiarity with Clinical Data Management processes, FDA regulations, SDLC methodologies, systems validation.
• Strong organizational skills with ability to effectively manage and guide teams involved in various projects
• Strong leadership skills
• Excellent technical writing and verbal communication skills.

Eisai Salary Transparency Language:

The base salary range for the Associate Director, Clinical Programming is from :165,800-217,600

Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.

Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits.

Certain other benefits may be available for this position, please discuss any questions with your recruiter.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status.  Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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