Senior Statistical Programmer - Pharma

Senior Statistical Programmer

About Domnic Lewis Group:

Domnic Lewis is a successful and innovative recruitment firm that works with Fortune 500 companies, has a strong commitment to diversity in hiring, and uses talent mapping as a key part of its recruitment process. The company operates in North America, India, and Australia, and has recently entered the gig hiring market by building communities. It has also been recognized for its efforts in diversity hiring through awards.

Currently we are looking for a "Statistical Programmer" for a leading innovator pharma MNC.

Job Location: Bangalore

What You will do:

- Lead Statistical programming deliverables for Regulatory submissions, including specification and delivery of datasets, outputs and response to regulatory questions; commercialisation and reimbursements

- Lead Statistical programming deliverables for Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models, following applicable data standards and regulations

- Lead Statistical programming deliverables for Development Safety Update Reports (DSUR), Periodic Benefit-Risk Evaluation Report (PBRER), Investigators brochures (IB)

- Contribute to the statistical programming thinking, analysis and reporting to relevant groups in product and study teams

- Contribute to the development of standard methodology to improve quality, efficiency and effectiveness

- Measure compliance to standards and automation use

- Employ good project management practices (estimation, risk management, status tracking) when planning and leading delivery

- Hold CRO/Partners accountable for the high-quality standards of their deliverables.

Essential Requirements:

- You are focused on solving challenging problems through collaboration and partnerships. You are a specialist in your field, or aspire to be a specialist, and you know that the best results are achieved by utilising the strengths of every individual.

- Degree in Mathematics (i.e., Applied Math, Engineering, etc.), Computer Science, Statistics, Life Sciences or similar area

- Strong experience in clinical drug development or healthcare

- Advanced SAS Programming, CDISC standards knowledge and industry best practices

- Excellent interpersonal skills

Desirable for the Role:

- Experience working in the Respiratory or Immunology therapeutic area

- Other programming languages e.g., S-PLUS, R, Python, XML etc.

- Extensive knowledge of Pinnacle 21 Validator