Principal Statistical Programmer

As a Principal Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities:

• Independently develop accurate and CDISC compliant ADaM specifications.
• Independently develop/validate programs that generate analysis datasets based on ADaM specifications.
• Independently develop/validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan (SAP).
• Good understanding of regulatory requirements. Prepare XPTs Define.xml, Reviewer’s Guide and analysis metadata report, executable programs for CRT packages.
• Run P21 checks and resolve the P21 validation report related error and document details.
• Perform quality control on final reports. Generate the adhoc and custom reports as requested.
• Provide QC and validation reports and document corresponding details.
• Communicate with programming and statistics leads, data managers and other team members.
• Provide project progress updates of programming activities.

Qualifications:

• BS/MS in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences - 10+ years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
• Required Skills Include: - Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Stat - Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio is a plus
• Experience with all clinical phases I, II, III and IV of trails is desirable
• Good understanding of standards specific to clinical trials such as CDISC, SDTM, ADaM, MedDRA, WHODRUG
• Strong problem-solving skills
• Good organizational and time management skills.
• Excellent communication and interpersonal skills and capability of communicating technical concepts
• Excellent organizational skills, demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.
• Should have experience in lead role.
• Experience in submission to regulatory authorities