Clinical Statistical Programmer

Create and Implement inhouse CDISC standards in SDTM & ADaM specifications and
datasets per Implementation Guides (IGs)
o Create SDTM specifications and map raw data to SDTM datasets.
o Validation of SDTM datasets by using available Validator.
o Create ADaM specifications and generate derived datasets.
Create and Review SDTM compliant annotated CRFs (aCRF) as per SDTM Mapping
specifications.
Support Data Management tasks by identifying raw data issues and creating reports for
clinical monitoring review
Review and provide input in Case Report Form (CRF) development and database build
Execute edit/logic checks to assist in data cleaning.
Implement and execute procedures to build and maintain database setup for paper
based and/or web based (EDC) clinical data management systems (CDMS) in standard
format or CDISC compliant format as required
Implement and maintain consistency checks in standard or CDISC format for database
builds in CDMS and EDC following and understanding Client and regulatory requirements.
Build SAS data sets from various data sources which meet provided specifications.
Write SAS programs to produce tables listings and graphs for ad hoc requests annual
progress reports clinical study reports integrated summaries publications and other
clinical research reports.

Job Description

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Collaborate with Biostatisticians Medical Writers/Monitors Regulatory Affairs and
Clinical Data Management teams to gather specifications for informative tables listings
and graphs.
Perform validation of the analysis data sets tables listings and graphs.
Participate in the review of Statistical Analysis Plan (SAP) and mock shells for Tables
Listings and Figures (TLFs)
Maintain and execute programs for the evaluation and validation of incoming clinical
data.
Accountable for first time quality on all deliverables.
Assist in providing technical solutions to client enquires.
Prepared SDRG (Study Data Reviewer Guide) per CDISC requirement
Gather and analyze programming requirements to develop clinical trial reporting systems.
Ensure adherence to service level agreements with regard to the turnaround time from
the point when specifications are finalized.
Maintain all supporting documentation for studies in accordance with
SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance. This
includes the documentation of any deviations and dissemination of these to the rest of
the project teams.
Maintain technical documentation that is applicable to the Clinical Database.

Utilize macro libraries and complex data step techniques to standardize programming.
Maintain and enhance existing programs for clinical studies.
Maintain detailed design specifications.
Ensure that programs and reports follow departmental/company standard operating
procedures.
Assist in the development of departmental systems and generate/maintain systems
documentation.
Participate and represent Statistical Programming function in the Clients Study
Management Team (SMT) meetings where needed.
Participate in the preparation of clinical and statistical summary reports.

Job Description

Confidential Page 3 of 3

Qualification and Experience
BSc or equivalent with research experience and/or MS (in a numerate discipline
preferably in Statistics Computer Science or Mathematics). Masters Degree preferred.
Minimum 4 years of experience as programmer with 2 year of SAS programming
preferably in a clinical or bioscientific environment
Must have handled at least a couple of Clinical studies independently meeting the
requirements of Statistical programmer
Experience on SDTM and AdaM data module and implementation guidelines is must
.
Experience in table and listing generation data extraction cleaning and derivation.
Proficiency in SAS Programming (Base Graph Macro and Stat).
Excellent programming skills in SAS/Python/R or dashboard applications
Proficient knowledge of clinical development process
Good understanding of GCP principles CDISC requirements and other regulatory
standards in Clinical Research and data management.
Knowledge of relational database design principles for the development of analysis

datasets is required i.e. combining multiple data sets indexing data aggregation sub
setting etc.

Familiarity with programming to generate summary statistics (mean median etc.) and
complex statistical methods (i.e. SAS GLM Logistic regression and survival analysis).
Resultsoriented with a good balance between quality and speed.