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Senior Statistical Programmer - Bengaluru, India - Lifelancer
Description
Who are we looking for?Qualifications and ExperienceBS or higher degree in Biostatistics,Mathematics, or related fields. Or a combination of education, training,
and work experience5-9 years of experience as a Statistical
Programmer in CROs, pharmaceutical companies, biotech companies, or
similarKnowledge of GCP and ICH GuidelinesExperience in business development
activities, supporting sales teams in the preparation of proposals, and
bid defensesExperience in the implementation of
technologies and process automatization within CROs, pharmaceutical
companies, biotech companies, or similarExperience in the implementation of
quality systemsSAS Certified Specialist:
Base
Programming Using SASSAS Certified Professional:
Advanced
Programming Using SASStrong analytic mindset and logical
thinking capabilityComputer and arithmetic knowledge, as
well as skills to adapt to different computer systemsAdvanced SAS programming and other
statistical softwareExcellent written and oral English
communication skillsAbility to define problems, collect data,
establish facts, and draw valid conclusionsAbility to communicate effectively with
appropriate internal and external contactsAbility to work on multiple projects and
to manage project timelinesGood organizational and time management
skills and initiativeGood communication and presentation
skillsGood people-skills and team playerYour responsibilitiesPrimarily working with the Data Managers,
Statisticians and Clinical Project Managers on ongoing clinical studies to
assure results are consistent with expectations, and quality control
procedures are followedParticipating in the creation and review
of key statistical documents including but not exclusive to:Case Report FormData SpecificationsData Transfer AgreementsStatistical Analysis PlanTables, Listings and Figures ShellsCDISC Mapping DocumentationLiaising with Statisticians and Data
Management and Biostatistics Managers at regular intervals to discuss
progress and any issues outstandingLiaising with personnel at the sponsor
company, or their designates, with Central Event Adjudication Committees,
Data Safety Monitoring Committees or any other third parties involved in
statistical programming activitiesDeriving and adapting data for analysis,
producing patient listings, summary tables, figures and patient profiles,
as part of SAS ProgrammingProducing or participating in the
validation of SDTM Domains based on the provided Specifications, including
Pinnacle 21 execution, producing or reviewing SDTM Specifications, SDTM
reviewer guides, Define.
XML, and any other documentation required for SDTM
derivation, producing or participating in the validation of ADaM Datasets
based on the provided Specifications, including Pinnacle 21 execution,
producing or reviewing ADaM Specifications, producing ADaM Reviewer
guides, Define.
XML, and any other documentation required for ADaM
derivation, as part of CDISC MappingTraining other project team members to
make full and correct use of the company procedures and Biostatistics
Reporting EnvironmentApplying company standards, and actively
participating in improvements towards harmonization and standardization
across projectsParticipating as necessary in sponsor
audits, regulatory authority inspections, and other third-party meetingsPerforming necessary administrative
functionsEntering and updating data in relevant
CTMS modulesPlease use the below link for job application and quicker