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Senior Statistical Programmer

3 months ago

Bengaluru, Karnataka, India Lifelancer Full time
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 response.