Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and cosmeceuticals. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.
In the frame of the growth of our business, we are looking for a:
The Biostatistician plays a critical role by providing statistical expertise and insights to support the clinical development team, ensuring that all statistical and programming deliverables meet the highest quality standard and are delivered in a timely manner. This position is part of the Clinical Development department of Teoxane SA and is based in Geneva, Switzerland.
Your main responsibilities:
- Develop the statistical sections of the clinical protocols and statistical analysis plans, including study design, statistical power and sample size calculations, subject randomization schemes.
- Develop the table and listing specifications, program and validate tables and listings, write the statistical analysis report.
- Provide expert statistical input and interpretation of results, data analysis, meta-analysis across studies, reporting and visualization.
- Coordinate and perform statistical oversight for outsourced studies and activities.
- Review and contribute to the clinical study reports and statistical sections of regulatory submission dossiers.
- Ensure adherence to ICH-GCP, FDA regulatory guidelines and internal SOPs.
- Participate in the development and maintenance of clinical study documents.
- Participate to vendors selection and RFP.
- Write and maintain the set of internal SOPs for biostatistics.
To be successful in this role, you will require the following qualifications:
- Minimum MSc. or PhD in biostatistics, statistics, or related discipline
- 3-5 years of experience in biostatistics and programming.
- Strong statistical methodology knowledge and implementation
- Proven experience in programming in SAS, other languages a plus
- Good organizational and analytical problem-solving skills
- Knowledge of ICH-GCP, FDA guidelines, CDISC and 21 CFR Part 11
- Team player, looking to be part and contribute to the team success
- Excellent interpersonal, verbal and written communication skills
- Fluent in English, French a plus