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Senior Director Biostatistics (Full-time)
ProQR Therapeutics is a clinical-stage biotech company listed on NASDAQ with offices in Leiden, the Netherlands and Cambridge, Massachusetts, US. ProQR is focused on the development of game changing RNA therapies for severe genetic rare diseases. Our mission is to help patients by creating new medicines. A team of 160 enthusiastic ProQRians from all walks of life and more than 30 different nationalities is up to this challenge. We have the passion and commitment to make a difference in the lives of the patients we serve.
Our Research & Development department is currently looking for a Senior Director Biostatistics (Full-time) to join our team. In this Senior Director-level position you will be reporting to the Vice-President, Clinical Development.
This is an excellent opportunity to join a well-funded Biotech company that has attracted a world-class management team where you will be responsible for directing all aspects of the design of clinical studies, helping with implementation of clinical trials, and preparation of reports relating to clinical trial outcomes.
In this Director Biostatistics leadership role, you will:
- Provide statistical input in the development of clinical study designs and strategy
- Give statistical input during the development of essential documents (incl. protocol, IB, study reports etc.)
- Lead the development of (interim) statistical analysis plans
- Ensure the appropriate statistical processes are in place
- Support translational activities: interpret preclinical data and apply to clinical program (incl. clinical design development/ clinical monitoring etc.)
- Support in ongoing statistical review and interpretation of clinical data
- Support explorative and post-hoc analyses
- Validation of new endpoints
- Liaise with collaborators, external experts etc. to accumulate clinical and scientific knowledge necessary to support the clinical development plans
- Ensure oversight of outsourced statistical activities
- Maintain knowledge of therapeutic area and current statistical practices
- Collaborate in CRO selection and feasibility assessments
Location: Remote (EU / US / Canada)
We expect our Director Biostatistics to have:
- MSc, MD or PhD with >5 years of experience in clinical development
- Excellent communication skills - verbal, presentation, and written (English is a must, Dutch is a plus)
- Demonstrated ability to work in a cross-functional environment
- Knowledge of clinical trial design and statistical methodology
- Experience working in Ophthalmology would be a plus
- Knowledge of data standards SDTM, ADaM
- Strong experience with SAS is desirable, and knowledge of JMP is also advantageous
- Strong data review and interpretation skills
- Experience in protocol design and development, study report preparation, Investigator´s Brochure preparation, and preparation and review of other study related documents
- Full understanding GCP and ICH Guidelines
- Aptitude for teaching
- Strategic, able to promptly identify issues and proactively propose solutions
- Able to work with remote colleague
Skills and competencies that are required for making the difference:
- Hands-on mentality
- Being able to work in a fast-paced environment
- Being able to prioritize multiple tasks
- Critical thinking, decision making and problem-solving skills
ProQR as an employer
As an employer, we are a true believer of the value of a workforce in which people from diverse backgrounds are encouraged to develop themselves, personally and professionally. We believe that happy and energized people, working well together in an environment in which they thrive, will do phenomenal and awesome things.
We are committed to ensure that no employee, candidate or job applicant receives less favorable treatment on the grounds of race, age, disability, pregnancy, religion, gender identity and expression, sexual orientation, marriage or civil partnership status. At ProQR we want to create an inclusive culture where everyone can be valued for who they are and in which individual differences and the contributions in all forms are recognized and valued.
We offer an exciting and innovative working environment in a very committed organization, with competitive benefits, including an annual performance bonus, stock options and flexible working arrangements. The salary and terms of employment will be discussed in detail at an appropriate stage of company interview.
Do you think you can contribute in achieving our mission? If so, we’re looking forward to receiving your application by filling out our application form.
Please apply as soon as possible if you are interested in this position.
You can contact Silvia Catellani via firstname.lastname@example.org if you have any questions.
Please note that a screening is part of our selection procedure.