Principal Statistical Programmer

3 weeks ago

Hyderabad, Telangana, India Statistics & Data Corporation (SDC) Full time

Job Title: Principal Statistical Programmer

Job Summary:

Statistics & Data Corporation (SDC) is seeking a highly skilled Principal Statistical Programmer to join our team. As a key member of our biometrics department, you will be responsible for providing statistical programming support to clinical trials. Your expertise will be crucial in producing statistical analyses, including generating/validating analysis datasets, tables, listings, and figures for clinical trials. You will also be responsible for creating SDTM mapping and datasets, developing and maintaining the infrastructure for project files of SAS datasets and SAS code, and supporting Data Management in data set creations/transfers, integrity checks, and quality audits.

Key Responsibilities:

  • Perform or oversee team in performing all statistical programming required for clinical trial analysis and reporting on large scale projects of high complexity
  • 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
  • Organize and 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 reviewers guide and analysis datasets reviewers 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
  • 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 by developing training plans and providing oversight of their work 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

Requirements:

We are seeking a highly skilled and experienced Principal Statistical Programmer with a strong background in statistical programming, data analysis, and clinical trials. The ideal candidate will have a Bachelor's degree in computer science, statistics or other related scientific field and at least eight years of relevant professional experience.

What We Offer:

Statistics & Data Corporation (SDC) is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. We offer a competitive salary, generous time off, attainable career advances, and positive work/life balance. We are committed to developing our employees and providing opportunities for growth and career advancement.

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