Statistics & Data Corporation (SDC)
Statistics & Data Corporation (SDC) Hyderabad Telangana India
2 weeks ago
Senior Statistical Programmer I
Statistics & Data Corporation (SDC), A global contract research organization (CRO) headquartered in Arizona, providing clinical trial solutions for pharmaceutical, biologic, and medical device/diagnostic companies since 2005. Our core expertise is strategic scientific consulting and clinical data services which include biostatistics, data management/EDC, and IRT/IWRS.
Provide statistical programming support to clinical trials. Produce statistical analyses, including generating analysis datasets, tables, listings, and figures for clinical trials. Create SDTM mapping and datasets. Develop and maintain the infrastructure for project files of SAS datasets and SAS code. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis.
• Perform all statistical programming required for... clinical trial analysis and reporting
• Apply appropriate statistical methods for data analysis and provide statistical programming expertise for project teams
• Review the Statistical Analysis Plan in preparation for programming the planned analyses
• Design/develop SAS macros and other utilities to expedite SAS programming activities
• Generate tables, listings, and figures per protocol, Statistical Analysis Plan, and/or approved client request
• Participate in statistical program validation and quality control activities
• Develop SDTM aCRF and specifications; complete programming and validation of CDISC SDTM and ADaM datasets
• Review ADaM specification documents and ensure the specifications meet the analysis criteria specified in the SAP
• Review pinnacle 21 reports and ensure compliance with CDISC and FDA guidelines
• Develop define.xml, study data reviewer’s guide and analysis datasets reviewer’s guide
• Actively participate in study team meetings
• Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects
• Participate in review process of study documents such as the CRF, edit check specifications, and database design specifications written by Data Management
• Program data cleaning checks, as necessary, to assist Data Management’s data cleaning activities
• Participate in installation/validation of statistical software packages throughout the software development lifecycle
• Develop and maintain the infrastructure for project files of SAS datasets and SAS code
• Mentor junior level statistical programmers
• Ensure all programming activities and processes performed are conducted according to SDC’s standard procedures and/or sponsor requirements
• Adhere to all aspects of the SDC’s quality system
• Comply with SDC’s data integrity & business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
• Strong analytical skills, with the ability to process scientific and medical data.
• Very strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS Macros
• Basic understanding of SAS/Graph
• Strong problem-solving skills
• Able to work independently
• Excellent knowledge of statistical programming
• Proficient in manipulating and analyzing SAS data
• Ability to identify data issues, present problems, and implement solutions.
• Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues
• Good organizational and time management skills, with the ability to multi-task
• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
• Solid understanding of CDISC SDTM and ADaM data models
• Strong interpersonal communication and presentation skills
Education or Equivalent Experience
• Bachelor’s degree in computer science, statistics or other related, scientific field and four years of relevant professional experience; or an equivalent combination of relevant education and/or experience
Hyderabad Telangana India
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