Clinical SAS Programmer

Job Title: Clinical SAS Programmer [(within Pharmaceutical & Biotech industry for SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model)]

Location: 100% Remote

Duration: 12 Months

Rate: $DOE/Hour on W2

Position: 4

CDISC - Clinical Data Interchange Standards Consortium

CDISC supports two major standards– SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model)

Experience Skill Matrix:

1. Clinical SAS Programmer: Years
2. Pharmaceutical & Biotech industry: Years
3. Base SAS programming (DATA step): Years
4. SQL programming (i.e., use of SQL pass-through or PROC SQL): Years
5. Complex statistical methods (i.e., SAS GLM, Logistic regression, and survival analysis): Years
6. CDISC (Clinical Data Interchange Standards Consortium) knowledge: Years
7. SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) dataset experience: Years

Qualifications:

• Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.
• 8 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.

Major Responsibilities/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 analyse 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