Clinical Statistical Programmer

Create and Implement inhouse CDISCstandards in SDTM & ADaM specifications and
datasetsper Implementation Guides (IGs)
o Create SDTMspecifications and map raw data to SDTM datasets.
oValidation of SDTM datasets by using availableValidator.
o Create ADaM specifications and generatederived datasets.
Create and Review SDTM compliantannotated CRFs (aCRF) as per SDTM Mapping
specifications.
Support Data Management tasks byidentifying raw data issues and creating reports for
clinical monitoring review
Review and provide input inCase Report Form (CRF) development and database build
Execute edit/logic checks to assist in data cleaning.
Implement and execute procedures to build and maintain databasesetup for paper
based and/or web based (EDC) clinicaldata management systems (CDMS) in standard
format orCDISC compliant format as required
Implement andmaintain consistency checks in standard or CDISC format fordatabase
builds in CDMS and EDC following andunderstanding Client and regulatory requirements.
BuildSAS data sets from various data sources which meet providedspecifications.
Write SAS programs to produce tableslistings and graphs for ad hoc requests annual
progressreports clinical study reports integrated summaries publicationsand other
clinical research reports.Job Description Confidential Page2 of 3
Collaborate with Biostatisticians MedicalWriters/Monitors Regulatory Affairs and
Clinical DataManagement teams to gather specifications for informative tableslistings
and graphs.
Perform validation ofthe analysis data sets tables listings and graphs.
Participate in the review of Statistical Analysis Plan (SAP) andmock shells for Tables
Listings and Figures(TLFs)
Maintain and execute programs for the evaluationand validation of incoming clinical
data.
Accountable for first time quality on all deliverables.
Assist in providing technical solutions to clientenquires.
Prepared SDRG (Study Data Reviewer Guide) perCDISC requirement
Gather and analyze programmingrequirements to develop clinical trial reportingsystems.
Ensure adherence to service level agreementswith regard to the turnaround time from
the point whenspecifications are finalized.
Maintain all supportingdocumentation for studies in accordance with
SOPs/Guidelines/Work Instructions to ensure traceability andregulatory compliance. This
includes the documentationof any deviations and dissemination of these to the restof
the project teams.
Maintain technicaldocumentation that is applicable to the ClinicalDatabase.

Utilize macro libraries andcomplex data step techniques to standardize programming.
Maintain and enhance existing programs for clinicalstudies.
Maintain detailed designspecifications.
Ensure that programs and reports followdepartmental/company standard operating
procedures.
Assist in the development of departmentalsystems and generate/maintain systems
documentation.
Participate and represent StatisticalProgramming function in the Clients Study
ManagementTeam (SMT) meetings where needed.
Participate in thepreparation of clinical and statistical summaryreports. Job DescriptionConfidential Page 3 of 3Qualification and Experience
BSc orequivalent with research experience and/or MS (in a numeratediscipline
preferably in Statistics Computer Science orMathematics). Masters Degree preferred.
Minimum 4 yearsof experience as programmer with 2 year of SASprogramming
preferably in a clinical or bioscientificenvironment
Must have handled at least a couple ofClinical studies independently meeting the
requirementsof Statistical programmer
Experience on SDTM and AdaMdata module and implementation guidelines is must
.
Experience in table and listing generation dataextraction cleaning and derivation.
Proficiency in SASProgramming (Base Graph Macro and Stat).
Excellentprogramming skills in SAS/Python/R or dashboardapplications
Proficient knowledge of clinicaldevelopment process
Good understanding of GCP principlesCDISC requirements and other regulatory
standards inClinical Research and data management.
Knowledge ofrelational database design principles for the development ofanalysis datasets is required i.e. combiningmultiple data sets indexing data aggregation sub
settingetc. Familiarity with programming togenerate summary statistics (mean median etc.) and
complex statistical methods (i.e. SAS GLM Logistic regression andsurvival analysis).
Resultsoriented with a good balancebetween quality and speed.

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