Principal/Lead Statistical Programmer

Job Title: Principal / Lead Statistical Programmer

Employment Type: Full time

Location: Bengaluru OR Hyderabad

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Job Responsibilities:

Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.

Develop SDTM specifications and generate SDTM datasets using SAS.

Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.

Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.

Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).

Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.

Analyze information and develop innovative solutions to programming and data analysis challenges.

Actively communicate with statisticians for statistical input and analysis interpretation.

Follow and reinforce regulatory agency requirements during daily job.

Serve as a programming team lead and contribute to department initiative.

Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.

Review draft and final production deliverables for project to ensure quality and consistency.

Education & Experience

Master's / Bachelor's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.

Should have 8-13 years of experience in Statistical Programming in Clinical domain.

Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.

Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members

Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.

In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.

Good understanding of clinical drug development process.

Strong communication skills and coordination skills. ability to communicate with global teams with supervision.

In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.

Good understanding of clinical drug development process.

Detail-oriented and ability to learn and adapt to changes.

Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.

ClinChoice is an Equal Opportunity Employer / Committed to Diversity