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