Associate Director, Biostatistics

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director, Biostatistics in India.

This senior scientific leadership role sits at the heart of global clinical development, driving the statistical integrity of clinical trials across all phases of drug development. You will play a key role in shaping study design, ensuring robust statistical methodology, and supporting high-impact regulatory submissions across global markets. Working in a cross-functional and highly collaborative environment, you will contribute directly to the quality and credibility of clinical evidence generated for innovative therapies. The role combines hands-on statistical expertise with strategic oversight, influencing both study-level decisions and broader development programs. You will interact closely with clinical, regulatory, data management, and medical writing teams while ensuring compliance with global standards and regulatory expectations. This position is ideal for an experienced biostatistician who thrives in a fast-paced pharmaceutical R&D environment and enjoys both scientific depth and leadership responsibility.

Accountabilities:

• Serve as study biostatistician across multiple clinical development programs and studies spanning Phase I–IV.
• Lead the development of Statistical Analysis Plans (SAPs), TFL shells, and other key statistical study documents.
• Oversee ADaM specifications, ensure high-quality generation of ADaM datasets and TFL outputs, and maintain delivery timelines.
• Provide statistical input for clinical study reports, regulatory submissions, and eCTD documentation for global health authorities.
• Conduct exploratory and ad hoc statistical analyses in collaboration with cross-functional study teams.
• Support regulatory interactions, including responses to health authority queries and data-related requests.
• Contribute to statistical innovation, including methodology development, simulation studies, and trial design optimization.
• Participate actively in cross-functional meetings and provide clear, scientifically sound statistical guidance.
• Support process improvement initiatives, SOP development, and internal training to strengthen statistical capabilities.
• Ensure adherence to internal SOPs and global regulatory requirements while maintaining high-quality deliverables.

Requirements:

• Ph.D. or M.S. in Biostatistics, Statistics, or a related quantitative discipline.
• 10+ years (Ph.D.) or 15+ years (M.S.) of industry experience in pharmaceutical or clinical R&D environments.
• Strong understanding of clinical drug development across Phase I–IV studies.
• Solid expertise in statistical methodologies, clinical data interpretation, and regulatory expectations.
• Proficiency in statistical programming tools such as SAS and R.
• Experience supporting NDA/BLA submissions and eCTD regulatory filings is highly desirable.
• Exposure to oncology or dermatology clinical development is a plus.
• Strong organizational and project management skills with the ability to handle multiple priorities.
• Excellent communication skills, with the ability to convey complex statistical concepts clearly.
• Strong attention to detail, accountability, and commitment to high-quality scientific output.
• Collaborative mindset with the ability to work independently when required in a fast-paced environment.
• Experience in global or publicly traded pharmaceutical environments is an advantage.

Benefits:

• Competitive compensation package aligned with senior pharmaceutical R&D roles.
• Opportunity to work on global clinical development programs with high scientific impact.
• Flexible remote or hybrid working arrangement.
• Strong emphasis on professional growth, learning, and continuous development.
• Collaborative and innovation-driven work culture within global cross-functional teams.
• Exposure to regulatory submissions and advanced clinical trial methodologies.
• Opportunity to contribute to high-value drug development programs improving patient outcomes worldwide.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1