Instagram
youtube
Facebook

Manager, Clinical Services

5+ years
Not Disclosed
10 July 24, 2025
Job Description
Job Type: Full Time Education: Master’s degree /PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.