Senior Statistical Programmer
- Compensation
- Not disclosed
- Location
- Hyderabad, India
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Contract
- Experience
- Not specified
- Category
- Not specified
- Posted
Skills
Must have
- • 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). Expert knowledge of CDISC SDTM and ADaM data models
- • Strong interpersonal communication and presentation skills
- • SAS Base, Advance, and Clinical Trials Certification is preferred
- Education or Equivalent Experience
- • Bachelor’s degree in computer science, statistics or other related, scientific field and at least six years of relevant professional experience; or an equivalent combination of relevant education an
Full description
Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.
Senior Statistical ProgrammerJob Summary
Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating 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.
Primary Responsibilities
- Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on medium to large scale projects
- 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
- Lead design/development of SAS macros and other utilities to expedite SAS programming activities
- Conduct internal training sessions and author papers for conferences
- 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 or review SDTM aCRF and specifications, ADaM specifications; complete programming and validation of CDISC SDTM and ADaM datasets
- 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
- Identify study priorities and communicate effectively with project team and management
- Ensure quality, proper documentation and meet or exceed timely completion of the project within budgeted hours
- Manage statistical programming timelines, budgets, and client expectations
- 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