Company:
Katalyst Healthcares & Life Sciences
Location: South Plainfield
Closing Date: 20/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Responsibilities:
Provides SAS programming support to all clinical studies.
Manages programming CROs providing oversight and appropriate QC for programming deliverables.
Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
Provides primary programming and QC support for any internally produced outputs.
Reviews and approves SAS programming instructions and CDISC/ADaM.
Perform complex statistical analysis and simulations using SAS to support clinical trial design and data interpretation.
Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming.
Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming.
Requirements:
Knowledge of pharmaceutical and regulatory requirements, procedures, and policies with a minimum of 5 years of pharmaceutical experience.
Experience with BLA or NDA/sNDA submissions is required.
Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
Knowledge of CDISC and Adam dataset structures and requirements.
Knowledge of all aspects of clinical drug development (Phase 1-4).
Experience working with and managing a CRO partner.
Excellent computer skills; strong verbal and written communication skills.
Ability to work well in a team environment as a contributor.
Provides SAS programming support to all clinical studies.
Manages programming CROs providing oversight and appropriate QC for programming deliverables.
Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
Provides primary programming and QC support for any internally produced outputs.
Reviews and approves SAS programming instructions and CDISC/ADaM.
Perform complex statistical analysis and simulations using SAS to support clinical trial design and data interpretation.
Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming.
Works closely with biostatisticians and data managers to identify data issues and generate queries that may impact statistical analysis and/or programming.
Requirements:
Knowledge of pharmaceutical and regulatory requirements, procedures, and policies with a minimum of 5 years of pharmaceutical experience.
Experience with BLA or NDA/sNDA submissions is required.
Knowledge of GCP, ICH, 21 CFR part 11, and other Guidance documents and policies related to clinical trials operations requirements.
Knowledge of CDISC and Adam dataset structures and requirements.
Knowledge of all aspects of clinical drug development (Phase 1-4).
Experience working with and managing a CRO partner.
Excellent computer skills; strong verbal and written communication skills.
Ability to work well in a team environment as a contributor.
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