Below are the JD’s. Please source SAS Clinical Programmer profiles for this
positions. client is Eisai(Pharma client) in NJ.*Eisai- Medical Affairs*














































*Biostat programmer - Commercial To support the Biostatistics team by
carrying out programming activities of statistical programmers and
overseeing external vendors (as required), and to ensure timely and
accurate programming and validation activities for clinical studies and
publications. Contributes to the overall efficiency and best practice of
the Biostatistics group, demonstrating the ability to work efficiently and
to a high standard within a clinical team environment. Main
duties/responsibilities: 1. Providing statistical programming and
validation support for clinical study reports, overseeing programming
activities by external vendors (e.g., CROs) when necessary and coordinating
programming activities among the study programmers to achieve timely
progress in the following areas: SDTM datasets, ADaM datasets, statistical
tables, figures, listings,and other internal and external requests (e.g.,
publications). Accessing and converting data to SAS from Database
management system and PC file formats (e.g., MS Excel, text files). Working
with external vendors in order to develop or monitor the content and
structure of SAS data sets. 2. Working closely with clinicians,
statistician, and publication managers to generate and QC outputs for
publications; review publication (abstract/manuscripts) to ensure accuracy,
quality and soundness of statistical methodologies; coordinate internal
resource utilization for publication and generate activities metrics for
management review. 3. Providing input to the Database and CRF Development,
creating edit check programs and providing feedback to the Data Management.
Providing input in developing statistical analysis plans, specifications of
analysis datasets, validation plans, and other related documents. 3.
Maintaining standards for programming activities. 4. Working independently
to accomplish tasks and goals defined by supervisor. Bringing in new ideas
to improve the programming process. Qualifications and education required:
• Minimum of Bachelor’s degree in Statistics, Computer Science,
Mathematics, or a related science discipline. Masters preferred. Experience
required: • Minimum 8+ years experience in SAS programming for phase I-IV
clinical trials in a pharmaceutical/CRO environment. FDA submission
experience preferred. • Some project experience in a pharmaceutical/CRO
programming environment or demonstrated leadership in a clinical
pharmaceutical/CRO environment. Skills and aptitude required: • Experience
using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office. • Experience in
CDISC data standards, e.g. SDTM and ADaM • Proven experience with Unix and
Windows operating systems. • Understanding of the software development life
cycle. • Understanding of FDA guidelines. • Good organization, time
management and attention to detail skills needed to work in a stressful
environment under tight deadlines while maintaining focus on details and
quality. • Applies good judgment and demonstrates initiative to resolve
issues. • Strong verbal, written and interpersonal communication skills
needed to work effectively in a team environment, managing that team as
required.*



Thanks and Regards,


Anil
Paradigminfotech

8830 Stanford Blvd,

Suite 312 Columbia, MD 21045

*Tel: 302-357-9154* <Tel:410-505-4123>

*recruite...@paradigminfotech.com* <recruite...@paradigminfotech.com> //
*www.paradigminfotech.com* <http://www.paradigminfotech.com/>





The best way to reach me is via email

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