Manager, Clinical Services – Statistical Programming (Noida & Hyderabad)
Job Summary:
Cencora is hiring a Manager, Clinical Services to provide expert statistical support for clinical trials and regulatory submissions. The ideal candidate will have 5+ years of experience in CDISC-compliant statistical programming, SAS, and R, focusing on integrated summaries of safety (ISS) and efficacy (ISE). This role offers the opportunity to collaborate with global teams and contribute to cutting-edge pharmaceutical projects.
Key Responsibilities:
Develop and execute statistical analysis plans for clinical trials.
Perform statistical programming using SAS and R, ensuring CDISC compliance.
Conduct integrated analyses for ISS and ISE across multiple studies.
Prepare datasets and documentation for regulatory submissions (FDA, EMA).
Generate tables, listings, and figures (TLFs) for CSRs and submissions.
Provide statistical input on study design, protocols, and sample size calculations.
Collaborate with cross-functional teams, including data management and medical writing.
Review and validate all statistical outputs for quality and regulatory compliance.
Stay updated with the latest advancements in biostatistics and regulatory guidelines.
Contribute to template development and process optimization to increase team efficiency.
Required Skills & Qualifications:
Master’s or Ph.D. in Statistics, Biostatistics, or related field.
5+ years of experience in clinical statistics, with expertise in CDISC standards.
Proficiency in SAS and R programming.
Experience with ISS and ISE development and regulatory submissions.
Strong understanding of ICH-GCP, clinical trial design, and data analysis.
Excellent problem-solving, communication, and project management skills.
Preferred Qualifications:
Experience in the pharmaceutical or biotechnology industry.
Knowledge of Python and familiarity with Agile/Scrum environments.
Experience working with international teams and regulatory agencies.
Perks & Benefits:
Competitive salary and benefits aligned with global pharma standards.
Work with cross-functional teams on international clinical projects.
Professional growth opportunities and skill development programs.
Collaborative work culture with cutting-edge tools and technologies.
Company Description:
Cencora, a global leader in pharmaceutical consulting and healthcare solutions, specializes in clinical services, regulatory compliance, and advanced drug development. With a focus on innovation and patient outcomes, Cencora empowers teams to deliver world-class healthcare solutions worldwide.
Work Mode: On-site – Noida & Hyderabad, India.
Call-to-Action:
If you are an experienced clinical statistician passionate about regulatory data analysis and statistical programming, apply now on the Cencora careers portal and take your career to the next level.
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