Statistical Programmer II

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About Princeps Technologies:

Princeps Technologies is a data-driven organization delivering advanced analytics and technology solutions to the pharmaceutical and biotechnology industries. We are committed to innovation, quality, and client success.

Role Overview:

Statistical Programmer II

Key Responsibilities:

• Develop and validate

  SDTM datasets

  based on CDISC standards.
• Create

  ADaM datasets

  in accordance with current ADaM implementation guidelines.
• Program

  Tables, Listings, and Figures (TLFs)

  as per sponsor requirements.
• Generate

  subject narratives

  using approved templates.
• Produce

  clinical registry files

  (e.g., ClinicalTrials.gov, EudraCT) and

  BIMO reports

  .
• Perform

  quality control (QC)

  and validation of all programming deliverables.
• Prepare and maintain

  specification documentation

  for datasets and outputs.
• Develop

  electronic submission packages

  that comply with global regulatory standards (FDA, EMA, etc.).
• Support

  data integration

  across studies for submission and cross-study analysis.

You Are:

• A SAS programmer with

  4+ years

  of experience in clinical trial data analysis.
• Proficient in

  SAS Base and Macro programming

  , especially for SDTM, ADaM, and TLFs.
• Familiar with clinical domains such as

  safety

  ,

  efficacy

  , and

  PK/PD

  .
• Knowledgeable of

  CDISC standards

  (ADaM, SDTM, Controlled Terminologies).
• Experienced in metadata programming and following sponsor-defined analysis standards.
• Exposure to

  Therapeutic Area User Guides (TAUGs)

  is a plus.

• R programming experience

  is an added advantage.
• Strong in documentation, QC, and regulatory compliance.

Preferred Qualifications:

• Bachelor's or Master’s degree in

  Statistics, Life Sciences, Computer Science

  , or related fields.
• Experience in preparing

  submission-ready data

  and documentation.
• Working knowledge of

  regulatory expectations

  from agencies like FDA and EMA.
• Effective communication skills and a collaborative mindset.

Why Join Princeps Technologies?

• Join a talented and mission-focused team.
• Contribute to global clinical research and regulatory innovation.
• Enjoy a supportive work environment with

  onsite collaboration

  in Hyderabad.
• Competitive compensation and

  professional development opportunities

  .