Company Description

Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Generous time off policy
• Summer Fridays
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Job Description

We are looking for someone to provide experienced statistical, scientific, and strategic support to the clinical and regulatory strategies across all phases of drug development, pre-clinical development, and marketing activities to maximize the benefit-risk of Sobi products. Depending on experience, the applicant may also take other roles as Product or Indication lead Statistician (multiple studies).

Key Responsibilities

• Responsible for the quality and timely delivery of the statistical analysis plan, the quality of statistical analyses, and interpretation of study results
• Responsible for all statistical aspects within the assigned program, providing statistical, scientific, and strategic expertise to quantify the benefit-risk 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.
• Provides leadership and project coordination to the statisticians working in the program, including in-house consultants and statisticians at CROs
• Accountable for the statistical content in the CSP and CSR as delegated by the Product Statistician

Scope of the Job (define the job as it relates to the larger scheme of the organization)

• Provides leadership to in-house consultants and statisticians at CRO working in the assigned studies.
• Provide statistical and strategic input to relevant documents in regulatory submissions, e.g. eCTD.
• Develops Statistical Analysis Plans for studies and regulatory submissions.
• Provides statistical input on a study level: contributes to establishment of Study protocols, Statistical Analysis Plans, CRF, as well as study report prototypes, i.e., Tables, Figures, and Listings.
• Ensures that the interpretation and presentation of results and the conclusions in the Clinical Study Report are scientifically justified by the study results.
• Provides programming support for in-house reporting, simulations, and exploration of data.
• Contributes to the development of CSRs.
• Provide statistical input in the evaluation and collaboration with CRO suppliers.
• Collaborates with internal statisticians and other functions in the department 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.
• Contributes to the development of SOPs as relevant.
• Participate in preparing responses to regulatory questions.
• Contribute with analyses/presentations and the writing of publications and abstracts in accordance with the publication strategy for the project.

Qualifications

Education/Learning Experience

Required:

• Master of Science (MSc) in mathematical statistics, statistics or equivalent.

Desired:

• PhD in mathematical statistics, statistics or equivalent

Work Experience

Required:

• 4 years of experience as a statistician in the pharmaceutical industry
• Previously working as a study statistician or equivalent
• Experience of statistical programming in SAS

Desired:

• Experience working in several phases of clinical development
• Experience of clinical program and study design and data analysis in using a variety of designs and statistical techniques
• Sound understanding of the regulatory environment within clinical development
• Experience of collaboration with statisticians and other functions at CROs around out-sourced clinical studies

Skills/Knowledge

Required:

• Sound knowledge of theoretical and applied statistics
• Relevant experience in using SAS
• Good understanding of SDTM and ADaM

Personal Attributes

Required:

• Strong written and oral communication skills
• Ability to communicate statistical information to non-statisticians

Desired:

• Strategic thinking and influencing skills
• Leadership skills

Languages

Required: Excellent writing and oral communication in English

Additional Information

The base salary pay range for this role is $XXX,XXX - $XXX,XXX annually. Actual pay for this position will take into account factors such as experience and location. In addition to a base salary, this position is also eligible for a competitive 401k match, short and long-term incentives, medical, dental, vision, STD/LTD and life insurance benefits, in addition to other health and wellness programs and offerings.

Reporting to

All Sobi employees need to demonstrate behaviors in line with Sobi's 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 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re 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 first-hand 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 ground-breaking 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 can’t 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 [email protected]

COVID-19 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 COVID-19 with proof of vaccination status. We will consider requests for reasonable medical or religious accommodations, as well as any state-specific exemptions, as required by applicable law.