Job Description
Company Overview
Sitero is a leading organization specializing in clinical research and healthcare solutions. We are dedicated to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to grow, we are seeking a highly motivated and detail-oriented Lead Statistical Programmer to join our team and contribute to our mission.
Position Overview
The Lead Statistical Programmer will bring statistical programming and clinical expertise to the creation of SDTM and AdaM domains, as well as tabulations, graphics and listings derived from clinical trial data. Responsibilities include programming Data Management Listings in accordance with sponsor requirements, preparing, documenting and testing necessary programs and ensuring that programming code adheres to regulatory and company standards. The role also involves performing quality assurance on work done by others, supporting production activities and assisting in training new employees.
Primary 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
Qualifications
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
8+ 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
Additional skill set
Ability to work in group setting and independently; ability to adjust to changing priorities
Excellent attention to detail and orientation toward meticulous work
Robust interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to project and maintain a professional and positive attitude
Working conditions
Travel: 5-20%
Lifting: 0-25 lbs
Other: Computer work for long periods of time
THIS POSITION DESCRIPTION SHOULD NOT BE DEEMED ALL INCLUSIVE. ADDITIONAL REQUIREMENTS AND EXPECTATIONS MAY BE ASSIGNED. AT ALL TIMES, EMPLOYEES ARE EXPECTED TO ADHERE TO COMPANY POLICIES AND COMPANY SOPS.

📌 Lead Statistical Programmer (Bengaluru)
🏢 Sitero
📍 Bengaluru