Clinical SAS Programmer

2 months ago

J P Nagar Bengaluru Karnataka, India Element Technologies Private Ltd. Full time

**QUALIFICATIONS - ESSENTIAL**
- Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.
- Min. 3-10+ years of SAS programming experience working with clinical trials data in the Pharmaceutical & Biotech industry.
- SAS certifications (Base, Advanced, etc.) are highly desired. Be proficient in Base SAS programming (DATA step), SQL programming (i.e., use of SQL pass-through or PROC SQL), as well as the SAS Macro language for use in making code more efficient.
- Familiarity with programming to generate summary statistics (mean, median, etc.) and complex statistical methods (i.e., SAS GLM, Logistic regression, and survival analysis).
- CDISC data models a necessity, especially **SDTM then ADaM**:

- CDISC knowledge
- SDTM and ADaM dataset experience
- Good written and spoken communications skills in English and thought-leadership skills.
- Must have knowledge and experience in **Python and R** Programming languages.

**MAJOR RESPONSIBILTIES/ACTIVITIES**:

- Performing data manipulation, analysis, and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming.
- Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).
- Develop SAS programs and generate complete, accurate and validated statistical TLGs in well-defined formats.
- Program SDTM and ADaM datasets according to the dataset specifications.
- Create SDTM annotated patient Case Report Forms.
- Perform data conversion between datasets with two different formats according to conversion requirements/specifications, e.g., converting from Excel data records to SAS datasets, non-CDISC compliant datasets to CDISC compliant datasets.
- Manage electronic data transfers from trial sponsors or other external clinical trial data vendors, such as central laboratories or other specialty laboratories.
- Document data and programming information in accordance with Corporate Governing Documents (Policies, SOPs, or Work Instructions).
- Archive clinical trial data (raw data, SDTM, and ADaM datasets) and programming documentation in accordance with Corporate Governing Documents and/or clinical trial sponsor's specific requirements.
- Write SAS programs to produce tables, listings, and graphs for ad hoc requests, annual progress reports, integrated summaries, publications, and other clinical research reports.
- Collaborate with Biostatisticians, Clinical Research Associates, Medical Writers, Regulatory Affairs and Clinical Data Management teams to gather specifications for informative tables, listings, and graphs.
- Build SAS data sets from various data sources which meet provided specifications.
- Execute edit/logic checks to assist in data cleaning.
- Maintain and execute programs for the evaluation and validation of incoming clinical data.
- Perform validation of the analysis data sets, tables, listings, and graphs.
- Utilize macro libraries and complex data step techniques to standardize programming.
- Maintain and enhance existing programs for clinical studies.
- Gather and analyze programming requirements to develop clinical trial reporting systems.
- 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 in the preparation of clinical and statistical summary reports

**Salary**: ₹500,000.00 - ₹3,500,000.00 per year

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

Ability to commute/relocate:

- J.P. Nagar, Bengaluru - 560078, Karnataka: Reliably commute or planning to relocate before starting work (required)

Expected Start Date: 01/03/2023

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