As a Senior Manager – Statistical Programming, you will serve as a technical leader within Global Development, providing oversight and guidance for statistical programming activities across multiple clinical programs. You will play a key role in delivering
high-quality, compliant data outputs for regulatory submissions, integrated analyses, and clinical trial transparency. This role will also focus on driving operational excellence, enabling innovation, and collaborating with cross-functional global teams to
ensure timely and accurate reporting aligned with industry and regulatory standards.
This position is office-based and will be on site at Hyderabad office.
A Typical Day May Include the Following:
- Act as a technical lead and primary point of contact for statistical programming activities across assigned projects and regions.
- Lead and oversee the development of integrated datasets (e.g., pooled ADaM) and analysis outputs for clinical studies and submissions.
- Ensure timely, high-quality delivery of programming outputs, adhering to internal standards and regulatory requirements.
- Collaborate with biostatisticians, data management, and cross-functional stakeholders to support clinical reporting and analysis needs
- Lead the preparation and review of electronic submission packages (eCTD) in compliance with global regulatory standards (FDA, EMA, PMDA).
- Support clinical trial transparency and disclosure activities, ensuring accurate and timely delivery of required datasets and outputs.
- Provide subject matter expertise in statistical programming, including development of tools, standards, and best practices.
- Drive process improvements and innovation initiatives to enhance efficiency, quality, and compliance across programming functions.
- Support inspection readiness activities and address regulatory queries related to programming deliverables.
- Mentor and guide team members, fostering capability building and promoting a culture of continuous learning.
- Collaborate across global teams to ensure alignment with enterprise standards and successful delivery of project milestones.
This Role May Be for You If You Have:
- Strong experience in statistical programming within clinical trials, including integrated analyses and regulatory submissions
- Deep understanding of CDISC standards (SDTM, ADaM, Define-XML) and regulatory requirements
- Proficiency in SAS programming, with additional exposure to R or Python considered beneficial.
- Experience with tools such as Pinnacle 21 (P21) for validation and compliance checks.
- Demonstrated ability to lead teams, manage multiple projects, and deliver results in a fast-paced environment.
- Strong analytical, problem-solving, and troubleshooting skills.
- Excellent communication and stakeholder management capabilities.
- Ability to work effectively in a matrixed, global organization and collaborate cross-functionally.
- High attention to detail with a focus on quality and compliance.
To Be Considered for This Role:
- 8+ years of relevant experience in statistical programming within pharmaceutical, biotech, or clinical research settings, including leadership experience.
- Bachelor’s degree required; Master’s degree or higher in Statistics, Computer Science, Mathematics, Life Sciences, or related field preferred.
- Proven experience supporting regulatory submissions and global compliance standards (FDA, EMA, PMDA).
- Strong experience working with clinical trial data and regulatory reporting processes.
- Prior experience in global or GCC environments is preferred.
- Fluency in English and ability to collaborate effectively with global stakeholders.
Pay: ₹2,400,000.00 - ₹3,600,000.00 per year
Work Location: Hybrid remote in Hyderabad, Telangana (Hyderabad, Hyderabad District)
