Manager, Clinical Services

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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.

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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 time

Affiliated CompaniesAffiliated Companies: PharmaLex Belgium SA

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned