Clinical SAS Programmer

5 months ago

Hyderabad Telangana, India Sciens Technologies Full time

Experience: Minimum 5 years in Clinical SAS Programming, preferably in ADaM (Analysis Data Model)

**Job Description**:
**Responsibilities**:

- Develop and validate SAS programs for the analysis and reporting of clinical trial data, adhering to industry standards and regulatory requirements.
- Generate analysis datasets, tables, listings, and figures (ADaM datasets) for clinical study reports, integrated summaries of safety and efficacy (ISS/ISE), and regulatory submissions.
- Collaborate with cross-functional teams including Biostatistics, Data Management, and Clinical Operations to ensure timely and accurate delivery of analysis results.
- Provide programming support for ad hoc data requests and exploratory analyses as needed.
- Contribute to the development and maintenance of standard programming macros, utilities, and documentation to enhance programming efficiency and consistency.
- Participate in internal and external audits as a programming representative, ensuring compliance with SOPs, GCP, and regulatory guidelines.
- Stay current with industry trends, regulatory updates, and emerging technologies in clinical SAS programming.

**Requirements**:

- Bachelor's or Master's degree in Computer Science, Statistics, Life Sciences, or related field.
- Minimum of 5 years of hands-on experience in SAS programming within the pharmaceutical or biotechnology industry.
- Proficiency in SAS programming including data step, procedures (e.g., PROC SQL, PROC REPORT, PROC FREQ), macros, and SAS/Base.
- Strong understanding of CDISC standards, particularly ADaM (Analysis Data Model) and SDTM (Study Data Tabulation Model).
- Experience working with clinical trial data and producing analysis datasets, tables, listings, and figures for regulatory submissions.
- Excellent communication skills with the ability to effectively collaborate with cross-functional teams and stakeholders.
- Detail-oriented with a commitment to producing high-quality work within project timelines.
- Familiarity with regulatory requirements (FDA, EMA, ICH) and industry guidelines (GCP, GCDMP) related to clinical trial conduct and data reporting.

Pay: From ₹1,000,000.00 per year

Schedule:

- Day shift
- Monday to Friday

**Experience**:

- SAS: 5 years (preferred)

Work Location: In person

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