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Job Details

Specialist in Pharmacometrics, apply his/her knowledge in pharmacology, sciences and

mathematics to the pharmacometrics (PK) / pharmacodynamic (PD) or modeling

and simulations (M&S) fields.

His/Her main tasks are

- Develop and execute appropriate pharmacometrics models, including population

PK/PD analyses, in collaboration with the scientific programmer and the sponsor

representative, as appropriate.

- Contribute to Protocol and Statistical/Pharmacometric Analysis Plan writing,

pharmacometric analysis of study data, Table Figure Listings production and

review, Clinical Study Report of early phases studies, …

- Develop and execute pharmacometric processes used as part of trial simulation

or of optimization of clinical trial design

- Perform problem solving: address identified issues (select an approach and get

the solution), report solutions to Project Leader, participate to team discussion

(identify issues, propose new approaches, ...)

For the GxP projects, the Specialist Pharmacometrics must ensure that the attributed study

phases are performed in accordance with the regulatory requirements, protocol,

statistical/pharmacometrics analysis plan and statistical/pharmacometric methodologies

and standards for the realization of the analysis. Depending on the project, his/her

responsibilities may include in particular the following tasks:

- Produce, qualify and review the Statistical/Pharmacometric Analysis Plan.

- Produce, qualify and review the programs.

- Produce, qualify and review any methodology/deliverables/results/outputs/reports

and amendments.

- Ensure that peer review or appropriate QC/validation is performed.

As every Project Team member, he/she conducts the project and informs about noncompliance or complaint.

The employee agrees to take over additional reasonable tasks that align with their abilities,

if required

.

Bachelor's degree in life sciences, business administration, supply chain, or a related field, or equivalent experience required. 2+ years of experience in quality assurance/quality management within a regulated and/or operational services environment (e.g., GxP/GDP, logistics/distribution, shared services, customer contact centers, or technology delivery), or a related field required. ASQ Certified Quality Auditor (CQA), Certified Professional in Healthcare Quality (CPHQ), ISO 9001 Lead Auditor (QMS), or equivalent certification preferred. Lean Six Sigma Green Belt or Black Belt certification preferred. ISTQB Certified Tester – Foundation Level (CTFL) or equivalent certification preferred.

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 Companies

Affiliated Companies: PharmaLex France SAS

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