Communicate with internal/client teams for project needs
Estimate scope of work and manage resources
Promote established standards and provide training/mentoring to team
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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
Ability to interpret project level requirements and develop programming specifications, as appropriate, for complex studies.
Provide advanced technical expertise in conjunction with internal and external clients, and independently bring project solutions to SP teams and Statistical Programming department, for complex studies.
Fulfil project responsibilities at the level of technical team lead for single complex studies or group of studies.
Directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines.
Estimate programming scope of work, manage resource assignments, communicate project status and negotiate/re-negotiate project timelines for deliverables.
Use and promote the use of established standards, SOP and best practices.
Provide training and mentoring to SP team members and Statistical Programming department staff.
Requirements:
Bachelor's degree from reputable university preferably in science/ mathematics related fields
Must have expertise of R programming as well as SAS® Base, and good knowledge of SAS® graph and SAS® Macros.
Capable of implementing more advanced statistical procedures as per specifications provided by biostatistician.
Must have excellent knowledge of CDISC standards (SDTM and ADaM).
Thorough understanding of relational database components and theory.
Excellent application development skills.
Good understanding of ICH E6, ICH E3, ICH E8, ICH E9 and clinical research processes.
Minimum of 4+ years of experience in Statistical Programming in pharmaceutical or medical devices industry
Good verbal and written communication skills.
Ability to work on multiple projects, plan, organize and prioritize activities.
Experience as technical team lead directly engaging clients and coordinating tasks within a programming team.
Knowledge of statistics, programming and/or clinical drug development process.
Advanced knowledge of R programming.
Base SAS, SAS/STAT, SAS Graph and SAS Macro Language.
Should have experience with SDTM Implementation and ADaM implementation according to CDISC Standards.
Must have expertise in SAS/BASE, SAS/MACRO, SAS/STAT, SAS/GRAPH, SAS/ACCESS, SAS/ODS, SAS/SQL.
Good organizational, interpersonal, leadership and communication skills.
Ability to independently manage multiple tasks and projects.
Ability to delegate work to other members of the SP team.
Excellent accuracy and attention to detail.
Ability to delegate work to other members of the SP team [SPM].
Exhibits routine and occasionally complex problem-solving skills.
Ability to lead teams and projects and capable of managing at a group level.
Recognizes when negotiating skills are needed and seeks assistance.
Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Required profile
Experience
Level of experience:Mid-level (2-5 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.