Principal Statistical Programmer

3 weeks ago

hyderabad, India EMentor Enterprises Private Limited Full time
Role: Principal StatisticalProgrammerExperience: 10yearsLocation: Hyderabad
PrimaryResponsibilities: ThePrincipal Statistical Programmer is responsible for leading anddeveloping highquality programming that support sponsors researchprograms at an expert level In addition the Principal StatisticalProgrammer has an active role in continuous improvement and isexpected to act as a leader in thedepartment.
TasksPerformed:
  • Follow thedepartment and company standard operating procedures (SOPs)policies and standards. Provide feedback and update theseguidelines as needed.
  • Using SAS perform SDTMADaM and table figure and listing (TFL) programming quality control(QC) review and create documentation of programs used in creatingstatistical outputs.
  • May perform role of LeadStatistical Programmer on studies portions of studies orprograms.
  • Act as expert in programming andClinical Data Interchange Standards Consortium (CDISC)deliverables.
  • Understand regulatory agencystandards and provide final deliverables in accordance with thesestandards (ie final CDISC deliverables for studies to be includedin Food and Drug Administration FDAsubmissions).
  • Collaborate with LeadBiostatisticians and the study team to resolve any studyrelatedquestions and ensure that programming outputs represent thestatistical analysis plan (SAP) and raw data from external sourcesand the clinical database.
  • Perform peer reviewand take accountability for ensuring programming accuratelyreflects the raw data.
  • Follow current SDTMstandards and current ADaM Implementation Guides. Lead studiesand/or studyrelated programmingactivities.
  • Perform review of the clinicaldatabase in regards to visit naming Clinical Data AcquisitionStandards Harmonization (CDASH) and accurate data collection toprovide clinical data that is analyzable and meets the needs of theBiostatistics team.
  • Understand timelines andmilestones affecting work.
  • Create Biostatisticsdeliverables that follow the protocol andSAP.
  • Understand and update SAS programs toadapt to various study situations and perform selfreview to ensureoutputs are as expected.
  • Accurately importexternal data to be used in TFLs.
  • Reconcileexternal data and provide findings for nonreconcilable items to theData Management team.
  • Interact with other staffmembers to understand and explain SAS programsaccurately.
  • Provide technical expertise forinternal and external clients and independently bring projectsolutions to the Biostatistics team and otherdepartments.
  • Analyze existing processes andexplore improvement solutions.
  • Develop and leadin intradepartmental or interdepartmental process and qualityimprovement initiatives.
  • Perform and plan thedevelopment implementation and validation of new processtechnologies macros and applications.
  • Overseedirect reports as assigned.
  • Mentor and trainprogrammers or other team members and/or develop training materialsas needed.
  • Other tasks asrequested.

sas,sdtm,deliverables,statisticalanalysis plans,cdisc standards,statistical programming,clinicaldata

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