Manual Release

QIJP00017091

Position: SAS Programmer (Statistical Programmer)

HM: Jayesh Patel

MSP: Abhipsa Mishra

Positions: 5

YOE: 8 - 10 Years

Duration: 1 Year (Auto-Renewal after initial year, could last as long as 3-4 years)

Interview: 3 (2 Technical and 1 Client Round)

Key Responsibilities

• SAS Programming: Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures. Perform programming validation to ensure the quality of analysis datasets and programming outputs.
• Project Support: Provide programming support for project teams, including the development of programming strategies, standards, specifications, and programmed analysis.
• Submission Preparation: Support the preparation and review of electronic submissions.
• Document Review: Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements. Assess the impact on programming activities.
• Vendor Interaction: Interact with vendors regarding project standards, programming conventions, programming specifications, and file transfers.
• Leadership: Provide leadership for ensuring the quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and work practices.
• Efficiency Improvement: Identify opportunities for increased efficiency and consistency within GBDS and interactions with strategic vendors.
• Independent Work: Independently lead and/or perform programming assignments with minimal supervision.
• Support Initiatives: Support improvement initiatives.
  
  

Minimum Requirements

Skills, Knowledge, and Experience:

• Education: Bachelor's degree in statistics, biostatistics, mathematics, computer science, or life sciences.
• Experience: At least 8 years of programming experience in the clinical industry.
• Analytical Programming: Demonstrated proficiency in analytical programming.
• Clinical Data Structure: In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases.
• Software Skills: Demonstrated skills in using software tools and applications, e.g., MS Office, XML, Pinnacle 21.
• Data Handling: Demonstrated ability in handling and processing upstream data (e.g., multiple data forms, workflow, eDC, SDTM).
• Output Provision: Demonstrated ability in providing outputs to meet downstream requirements (e.g., ADaM, Data Definition Table, e-submission).
• Regulatory Knowledge: Good understanding of regulatory, industry, and technology standards and requirements.
• Statistical Knowledge: Good knowledge of statistical terminology, clinical tests, medical terminology, and protocol designs.
• Teamwork: Demonstrated ability to work in a team environment with clinical team members.
  
  

Preferred Requirements:

• Experience: Minimum of 10 years of clinical/statistical programming experience within pharmaceutical clinical development, supporting regulatory filings (e.g., NDA, BLA, MAA).
• Drug Development Process: Knowledge of the drug development process, clinical trial methodology, statistics, and familiarity with global regulatory requirements.
• Additional Software: Experience in other software packages (e.g., R).
• Operating Systems: Experience with the Linux operating system.