Director of Biostatistics

Statistical Science Director provide highly experienced statistical scientific and strategic support to the clinical and regulatory strategies across all phases of drug development inlicensing opportunities preclinical development marketing activities other specialised areas and/or line functions (e.g. drug safety clinical pharm) to maximise the benefitrisk of Sobi products.

The Statistical Science Director is typically taking the role as the Product Statistician.

The Product Statistician:

• is accountable for the overall quality and the timely delivery of the statistical analyses for the assigned products
• is accountable for all statistical aspects within assigned products providing statistical scientific and strategic expertise to quantify the benefitrisk value and uncertainty of the emerging product profile throughout all phases of the drug development process in compliance with Sobi SOPs and regulatory requirements/guidelines.
• is accountable for leading the statistical thinking and contributions to the creation and development of TPP/TPC Target Label and Clinical Development Plans as well as to the Regulatory and Commercial Strategies for Sobi products.
• provides leadership and project coordination to all statisticians working in the project including inhouse consultants and statisticians at CROs
• is accountable for the statistical content in the CSP and CSR  

The Statistical Science Director is qualified for membership of the Study Document Review Forum (SDRF) and may also participate in inlicensing projects or work in other roles as appropriate.

The Statistical Science Director is responsible for coaching and developing less experienced statisticians.

Product Statistician:

• Provide leadership and project coordination to all statisticians working in the project including inhouse consultants and statisticians at CRO
• Provide statistical and strategic input into the establishment of a focused aligned and achievable Target Product Profile (TPP) and Target Labels
• Provide statistical and strategic input into the design and preparation of the Clinical Development Plan (CDP) ensuring alignment with the TPPs and Target Label
• Provide statistical and strategic input to relevant documents in regulatory submissions e.g. eCTD
• Take a proactive role in designing innovative studies and programs including Go/No Go criterion and associated risk levels to meet project objectives and regulatory requirements
• Approve and sign CSPs including the statistical content
• Approve Statistical Analysis Plans for studies and regulatory submissions
• Approve and sign CSRs including the statistical analysis and clinical interpretation of study data
• Participate in preparing responses to regulatory questions
• Provide statistical and strategic input into other regulatory documentation e.g. CSP CSR IB PSUR and RMP
• Participate in developing the publication strategy as a member of the publication team
• Contribute to the writing of publications and abstracts in accordance with the publication strategy for the project as applicable
• Ensure high quality statistical support for projects through the evaluation of CRO suppliers and provide input into outsourcing strategy and processes
• Collaborate with internal statisticians to drive best practices and implement new initiatives
• Stay informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings.
• Contribute to the development of SOPs as relevant

As SDRF statistician

• Participate in the review and approval of study essential documents in the role as a projectindependent statistician

Qualifications :

Education/Learning Experience

Required:  Bachelor of Science (BSc) in mathematical statistics statistics or equivalent.

Desired:  Master of Science (MSc) or PhD in mathematical statistics statistics or equivalent

Work Experience

Required:

• 8 years of experience as a statistician in the pharmaceutical industry
• Previous leadership experience from project and/or line management
• Extensive experience working in phase II III and IV programs and/or studies
• Extensive experience of clinical program and study design and data analysis in using a variety of designs and complex statistical techniques with different types of data and issues
• Experience of major regulatory submissions and/or previous attendance at meetings with regulatory authorities

Desired:

• Experience working in all phases of clinical development
• Extensive experience of regulatory submissions and previous attendance at meetings with regulatory authorities in more than one region e.g. Europe US Japan and China
• Experience of collaboration with statisticians and other functions at CROs around outsourced clinical studies

Skills/Knowledge

Required:             

• Comprehensive knowledge of clinical and pharmaceutical drug development
• Sound knowledge of theoretical and applied statistics
• Ability to find innovative approaches to trial design and analysis
• Sound understanding of the regulatory environment within clinical development
• Ability to be the statistical representative from the company at regulatory interactions
• Ability to coach less experienced statisticians in all aspects of their role.

Personal Attributes

Required: 

• Excellent written and oral communication skills
• Strategic thinking and influencing skills
• Ability to communicate statistical information to nonstatisticians
• Strong ability to collaborate and contribute in global crossfunctional teams
• Leadership skills

Languages

Required: 

• Excellent writing and oral communication in English

Additional Information :

All Sobi employees need to demonstrate behaviors in line with Sobis core values: Care Ambition Urgency Ownership and Partnership. Are you ready to be on the Sobi team Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us

We are a global company with over 1700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our daytoday wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package to support the health and happiness of our staff.

Sobi Culture

At Sobi we refuse to accept the status quo. This is because we have witnessed firsthand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into groundbreaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

An Equal Opportunity Employer

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs job requirements and individual qualifications without regard to race color religion or belief national social or ethnic origin sex (including pregnancy) age physical mental or sensory disability HIV Status sexual orientation gender identity protected veterans and/or expression marital civil union or domestic partnership status past or present military service family medical history or genetic information family or parental status or any other status or protected groups by the laws or regulations in the locations where we operate.

Sobi is an affirmative action and equal opportunity employer. Disabled/Veterans. If you are a qualified individual with a disability or a disabled veteran you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to

COVID19 Policy

For the safety of our employees and all individuals with whom we interact professionally Sobi North America requires all new hires in the U.S. to be fully vaccinated for COVID19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations as well as any statespecific exemptions as required by applicable law.