Offer summary

Qualifications:

Minimum of 5 years of experience in developing software for clinical trials using the SAS system., Skilled in programming with SAS; knowledge of additional programming languages is a plus., Good knowledge of statistics and the drug development process., Experience with CDISC standards, including SDTM and ADaM models..

Key responsabilities:

Attend multi-disciplinary team meetings to represent the programming function.

Create or review programming plans and key study-related documents.

Develop software systems for generating clinical study data displays for regulatory submission.

Create and maintain department SOPs related to clinical programming.

Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing

Job description

Responsibilities:

Attending multi-disciplinary team meetings, representing the programming function.
Create or review and approve programming plans at study and project level.
Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
Assist statisticians by suggesting algorithms to address Client analysis requests
Develop software validation procedures and test plans, as necessary.
Create and document archives of software, outputs, and analysis files.
Create and maintain department SOPs related to clinical programming.

Requirements:

Minimum of 5 years of experience in developing software for clinical trials using the SAS system
Skilled in programming with SAS. Knowledge of additional programming languages a plus.
Good knowledge of statistics and drug development process
Experience as a lead programmer for NDAs/BLAs
Experience overseeing the work of internal contractors and external vendors (CROs)
Experience in pharmacokinetics/pharmacodynamics modeling a plus
Familiarity with CDISC standards, including SDTM and ADaM models
Solid verbal and written communication skills