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
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