Job Summary

Startup Inno is seeking a highly skilled and detail-oriented Senior Statistical Programmer – Clinical Trials to join our growing clinical research and data science team. In this senior role, you will be responsible for leading the programming and statistical reporting activities for clinical trials across multiple therapeutic areas. You will play a critical role in transforming complex clinical data into high-quality, regulatory-compliant statistical outputs that support clinical study reports, regulatory submissions, and scientific publications.

As a senior professional, you will collaborate closely with biostatisticians, clinical data managers, medical writers, and cross-functional stakeholders to ensure the integrity, accuracy, and efficiency of statistical deliverables. This position offers an excellent opportunity to contribute to innovative healthcare solutions while mentoring junior programmers and shaping best practices in statistical programming.

Key Responsibilities

• Lead the design, development, and validation of statistical programs for clinical trials using SAS, R, or equivalent tools.

• Generate and review TLFs (Tables, Listings, and Figures) in accordance with study protocols and Statistical Analysis Plans (SAPs).

• Develop and maintain CDISC-compliant datasets, including SDTM and ADaM.

• Perform quality control (QC) and validation of statistical outputs to ensure regulatory standards and data integrity.

• Collaborate with biostatisticians to implement complex statistical methodologies.

• Support regulatory submissions (FDA, EMA, PMDA, etc.) by preparing compliant datasets and documentation.

• Mentor and guide junior programmers, providing technical leadership and best practice recommendations.

• Contribute to the development of standard macros, reusable code libraries, and programming guidelines.

• Participate in cross-functional meetings to provide statistical programming expertise.

Required Skills and Qualifications

• Bachelors or Masters degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related field.

• Strong proficiency in SAS programming; knowledge of R or Python is an added advantage.

• In-depth understanding of CDISC standards (SDTM, ADaM, Define.xml).

• Solid knowledge of clinical trial processes and regulatory requirements.

• Experience in producing TLFs and statistical reports for Phase I–IV studies.

• Strong analytical, problem-solving, and attention-to-detail skills.

• Excellent written and verbal communication skills.

• Ability to manage multiple projects and work in a fast-paced environment.

Experience

• 6+ years of experience in statistical programming within the pharmaceutical, biotech, or CRO industry.

• Proven experience working on global clinical trials and regulatory submissions.

• Prior experience in leading projects or mentoring junior team members is highly desirable.

Working Hours

• Full-time position, 40 hours per week.

• Flexible working hours with the option for remote or hybrid work, depending on location and project needs.

Knowledge, Skills, and Abilities

• Advanced knowledge of clinical trial data structures and statistical methodologies.

• Ability to interpret protocols, SAPs, and regulatory guidelines.

• Strong organizational and documentation skills.

• High level of accuracy, integrity, and accountability.

• Ability to work independently as well as collaboratively in cross-functional teams.

• Adaptability to evolving technologies and industry standards.

Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Flexible work arrangements and work-life balance initiatives.

• Continuous learning and professional development opportunities.

• Access to cutting-edge tools, technologies, and training.

• Inclusive and collaborative company culture.

Why Join Startup Inno

At Startup Inno, we are driven by innovation and a passion for improving patient outcomes through data-driven healthcare solutions. You will be part of a dynamic and forward-thinking team that values expertise, creativity, and collaboration. We offer a supportive environment where your contributions are recognized, your ideas are valued, and your career growth is actively encouraged.

Joining Startup Inno means working on impactful projects, shaping the future of clinical research, and being part of a company that truly believes in empowering its people.

How to Apply

Interested candidates are invited to submit their updated resume and a brief cover letter outlining their relevant experience and interest in the role. Applications can be sent via our official careers portal or directly to the Startup Inno recruitment team. Shortlisted candidates will be contacted for technical and behavioral interviews.