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Statistical Programmer II

at Altasciences in Overland Park, Kansas, United States

Job Description

Statistical Programmer II
Virtual
 Req #2831
Thursday, June 23, 2022

is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacologyand proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

JOB DESCRIPTION
Job Title
Statistical Programmer II
Department
Biostatistics
Primary Responsibilities
The Statistical Programmer II is responsible for proficiently developing high-quality programming that support sponsors' research programs. In addition the Statistical Programmer II is responsible for successfully performing the role of Lead Statistical Programmer for assigned innovator projects.
Tasks Performed
* Follow the department and company standard operating procedures (SOPs), policies, and standards.
* Using SAS, perform SDTM, ADaM, and table, figure, and listing (TFL) programming, quality control (QC) review, and documentation of programs used in creating statistical outputs.
* Understand regulatory agency standards and provide final deliverables in accordance with these standards (ie, final Clinical Data Interchange Standards Consortium [CDISC] deliverables for studies to be included in Food and Drug Administratin [FDA] submissions).
* Collaborate with Lead Biostatisticians to resolve any study-related questions to ensure that programming outputs represent the statistical analysis plan (SAP) and raw data from external sources and the clinical database.
* Perform peer review and take accountability for ensuring programming accurately reflects the raw data and population flags.
* Follow current SDTM standards and current ADaM Implementation Guides.
* Lead studies or portions of studies from a programming perspective as assigned. Monitor study progress and quality of other assigned programmers to meet quality and timeline expectations, escalate to management as needed.
* Perform review of the clinical database in regards to visit naming, Clinical Data Acquisition Standards Harmonization (CDASH), and accurate data collection to provide clinical data that is analyzable and meets the needs of the Biostatistics team.
* Understand timelines and milestones affecting work.
* Create Biostatistics deliverables that follow the protocol and SAP.
* Understand and update SAS programs to adapt to various study situations and perform self-review to ensure outputs are as expected.
* Accurately import external data to be used in TFLs.
* Reconcile external data and provide findings for non-reconcilable items to the Data Management team.
* Interact with other staff members to understand and explain SAS programs accurately.
* Analyze existing processes and explore improvement solutions.
* Provide technical expertise for internal and external clients, and independently bring project solutions to the Biostatistics team and other departments.
* Participate in intradepartmental and interdepartmental process and quality improvement initiatives.
* Perform and plan the development, implementation, and validation of new process technologies, macros, and applications.
* Mentor and train programmers or other team members and/or develop training materials as needed for their areas of expertise.
* Other tasks as requested.
Communication
Internal: Intradepartmental and interdepartmental throughout the organization. External: Client
Qualifications
Educational:
Bachelor's Degree in programming, health-related sciences, or relevant field
Skills :
* Excellent verbal and written communication skills.
* Professional attitude and strong interpersonal skills.
* Ability to work well with a multi-disciplinary team of professionals.
* Client-focused approach to work.
* Flexible attitude with respect to work assignments and new learning.
* Ability to prioritize workload.
* Superior attention to detail.
* Understanding of clinical research and the relationship of Data Management in the clinical study process.
* Strong technical aptitude and ability to adapt to multiple data management platforms.
* Good computer skills (Microsoft Word, Excel, and Power Point) and... For full info follow application link.

Altasciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.        
        
        

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Job Posting: 12090507

Posted On: Jun 23, 2022

Updated On: Jun 23, 2022