Senior Biostatistician

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 env