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Job Details
Job Summary:
We are seeking a highly skilled Clinical Statistician with extensive experience in CDISC-compliant statistical programming. The ideal candidate will be responsible for providing statistical support for individual clinical trials as well as integrated summaries of safety (ISS) and efficacy (ISE). This role requires a deep understanding of clinical trial design, data analysis, and regulatory requirements.
Key Responsibilities:
Develop and execute statistical analysis plans for clinical trials.
Perform statistical programming using SAS and R, ensuring compliance with CDISC standards.
Conduct integrated analyses for ISS and ISE, ensuring consistency and accuracy across studies.
Leverage experience (if applicable) to support the preparation of datasets and documentation for regulatory submissions, such as ISS/ISE, in line with global standards (e.g., FDA, EMA)
Generate tables, listings, and figures (TLFs) for clinical study reports (CSRs) and regulatory submissions.
Collaborate with cross-functional teams, including clinical research, data management, and medical writers, to ensure accurate and timely delivery of statistical outputs.
Provide statistical input for study design, protocol development, and sample size calculations.
Review and validate statistical deliverables to ensure quality and compliance with regulatory guidelines.
Stay current with industry trends and advancements in statistical methodologies.
Contribute to process optimization and development of templates, or standardized processes to enhance team efficiency and consistency.
Qualifications:
Master's or Ph.D. in Statistics, Biostatistics, or a related field.
Minimum of 5 years of experience in clinical statistics, with a focus on CDISC-compliant statistical programming.
Proficiency in SAS and R programming, in aim of increasing efficiency.
Experience with integrated summaries of safety (ISS) and efficacy (ISE).
Strong understanding of clinical trial design, data analysis, and regulatory requirements.
Excellent problem-solving skills and attention to detail.
Strong communication and interpersonal skills, with the ability to guide diverse groups of people through complex processes in a team environment.
Ability to manage multiple projects and meet deadlines in a fast-paced environment.
.
Preferred Qualifications:
Experience in the pharmaceutical or biotechnology industry.
Knowledge of other programming languages (e.g., Python) is a plus.
Familiarity with regulatory submission processes (e.g., FDA, EMA).
Experience in management, Agile/scrum-type experience is a plus.
Experience of working with international teams remotely is a plus.
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full timeAffiliated Companies
Affiliated Companies: PharmaLex Belgium SAManager, Clinical Services • Hyderabad, India
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