Please send me suitable resumes to *santh...@verticalfocus.co
<santh...@verticalfocus.co>* or call on *610-719-3228.*
Job Title : BioStat Programmers
Location : NJ
Duration : 6+ months
To support the Biostatistics team by carrying out and overseeing
programming activities of statistical programmers and external vendors (as
required), and to ensure timely and accurate programming and validation
activities for clinical studies. Contributes to the overall efficiency and
best practice running of the Biostatistics group, demonstrating the ability
to work efficiently and to a high standard within a clinical team
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:
analysis datasets, statistical tables, figures, listings, Integrated
Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE),
electronic submissions 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. Developing and maintaining SOPs, SWPs and other related technical
documents, 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.
Determining and researching SAS software upgrades and related systems and
addressing maintenance issues.
3. Managing and developing team, maintaining standards for programming
activities, and guiding/coaching Statistical programmers.
4. Working independently to accomplish tasks and goals defined by
supervisor. Attending required training and meetings and bringing in new
ideas to improve the programming process.
* Responsibilities weighting may change significantly based on the
incumbent and their assigned areas of responsibility.
Qualifications and education required:
• Minimum of Bachelor’s degree in Statistics, Computer Science,
Mathematics, or a related science discipline. Masters preferred.
• Minimum 5 years experience in SAS programming for phase I-IV clinical
trials in a pharmaceutical/CRO environment. 7+ years experience preferred.
• Some project experience in a pharmaceutical/CRO programming environment
or demonstrated significant leadership of SAS programming activities in a
clinical pharmaceutical/CRO environment.
Skills and aptitude required:
• Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.
• 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.
*Santhosh Reddy Patlolla*
*Vertical Focus Inc*
*610-719-3229 x 303 *
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