Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a CMC Statistician Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Main Job Tasks and Responsibilities:

The CMC Statistician Consultant provides statistical consultancy in a CMC context for both biological & chemical molecules, in relation with method/process development, robustness, equivalence, validation & transfer, specification determination, process optimization and control.

Key Responsibilities:

She/he will provide statistical consultancy for both biological & chemical molecule, in relation with method robustness & equivalence, process comparability and validation, specification determination, process optimization and control. The person will be responsible for:

• Designing experiments and performing statistical analysis for product development and manufacturing.
• Writing reports and/or presentations for internal and/or external clients, including Regulatory Authorities.
• Review team members’ technical reports for programming, statistical and mathematical accuracy.
• Actively participate in project team meetings to understand the context for application of statistical methods
• Work on multiple projects simultaneously, meeting timelines, and delivering on commitments.
• Continue to advance your knowledge of applicable statistical methods through literature, training, and online resources.

Education and qualification:

• Master degree in statistics (with BCs in Mathematics) , PhD in statistics is a plus
• Min years’ experience required: 2-4 years of experience as statistician in product development within the pharmaceutical industry.

Competencies:

• Educated on commonly used statistical methods, such as Design of Experiments (DOE), linear and nonlinear regression modeling, variance component analysis, multivariate analysis, equivalence testing, process capability and control charts
• Knowledge about Bayesian statistics is a plus
• Programming skills using with R, JMP and SAS (base, stat) is expected. Other statistical packages knowledge is an asset (Python, …).
• Excellent verbal and written communication skills
• Ability to work effectively, both independently and as part of teams
• Capacity to handle multiple projects in a fast-paced environment
• Scientifically curious, pragmatic, and driven to succeed
• Personable, organized, and detailed oriented
• Experience in multidisciplinary projects.
• Fluent English is required, French is a plus.

We look for someone who has a good customer oriented view and who has the flexibility and willingness to develop a good base understanding (not directly linked to statistics) of the different supported areas (bioassays, analytical chemistry, process chemistry, packaging, etc) . She/he must be capable to deal with very different issues coming from different areas at the same time.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

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