Statistical Programmer Ii

1 week ago


Bengaluru Karnataka, India Sitero LLC Full time

**Statistical Programmer II**

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

Job Title: Senior SAS Programmer

Location: Bangalore/Mysore, Karnataka

Function: Clinical Services

**SUMMARY**:
Senior Clinical Programmer Analyst will provide statistical programming and clinical expertise in the production of SDTM and AdaM domains, tabulations, graphics, and listings from clinical trial data. Prepare, document and test required programs and ensure programming code meet regulatory and company standards. Perform quality assurance procedures on work performed by others. Support of production activities, assist in the trainings for new employees.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

- Provides_ _data_ _to_ _clients_ _(internal_ _and_ _external)_ _in_ _functional_ _format_ _by:_
- Creating and executing SAS edit check programs
- Validating edit check programs using standard validation practices and processes
- Developing SAS programs that convert data from EDC to protocol-specific SAS datasets in accordance with customer specifications
- Assist with the creation of SAS-related project programming and validation documentation
- Assist with the creation of SAS macro and format libraries
- Ensures_ _the_ _quality_ _of_ _our_ _client's_ _data_ _and_ _data_ _export_ _by_
- Reviewing and approving User Requirement Specifications (URS), Clinical Data Management (CDM) conventions, and working procedure documents
- Developing and implementing new CDM systems and enhancements to current CDM systems
- Understand, create, and communicate information about creating CDISC-compliant datasets
- Create documentation related to the generation of customer specific SAS datasets
- Maintain the SAS environment by providing assistance in SAS installation, updates, and maintenance
- Assist the Study Quality Representative in the testing of protocol specific SAS conversion programs
- Ensures_ _project_ _timelines_ _as_ _they_ _relate_ _to_ _Clinical_ _Data_ _Management_ _operations_ _by_
- Assessing and assigning target dates for project timelines in conjunction with manager
- Adhering to target dates for project timelines
- Communicating any changes in target date to appropriate personnel including
- Project Manager Keeping department head informed of current issues
- Maintains departmental productivity and identifies opportunities for greater departmental efficiencies and quality by
- Coordinating activities of the Clinical Programming department with related activities of other departments (operations programming, study QA, PM and DM) to ensure efficiency
- Evaluating current procedures and work instructions for accomplishing department objectives in order to develop and implement improved procedures
- Assisting the training department with the development and maintenance of Clinical Programming training materials

**Secondary**Responsibilities**
- Contributes_ _to_ _team_ _effort_ _by:_
- Exploring new opportunities to add value to organization and departmental processes Helping others to achieve results Performing other duties as assigned and deemed necessary
- _Maintains_ _Technical_ _Knowledge_ _by:_
- Attending and participating in applicable company sponsored training
- _Maintains_ _Quality_ _Service_ _and_ _Departmental_ _Standards_ _by:_
- Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”) Assisting in establishing and enforcing departmental standards Reviewing and providing recommendations to management on operational procedures, and participating in process improvement initiatives

EDUCATION AND EXPERIENCE REQUIRED:
Education
- Bachelor’s degree in computer science, design or related field required
- Educational background in human-computer interaction, usability, user-centered design, user experience, information design, applied psychology, cognitive science, human factors, informatics, computer science, or other design/applied science fields is a plus.

Experience
- 6+ Years of experience, SAS programming experience in pharmaceutical related industry - Required
- 5+ Years of experience, Experience working with CDISC, SQL, and Relational Databases - Required
- 3+ Years of experience, understanding of database organization and how to extract data to generate listings and reports
- Required

PREFERRED SKILLS:

- Ability to work in group setting and independently; ability to adjust to changing priorities
- Excellent attention to detail and orientation toward meticulous work
- Strong interpe



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