Additionalinformation

Additional Information

Companydescription

Company Description

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.

Senior Statistical Scientists provide experienced statistical, scientific and strategic support across assigned studies or indications. The role is differentiated from Statistical Scientist by broader responsibility and increased independence.

The Senior Statistical Scientist is typically taking the role as Study Statistician for multiple, complex or business critical studies, but may also work as a Program Statistician or in other roles as appropriate.

Jobdescription

Job Description

Key Responsibilities

The Study Statistician:

• is responsible for the overall quality and the timely delivery of the statistical analyses for assigned studies in compliance with Sobi SOPs and regulatory requirements/guidelines
• provides leadership and oversight to in-house consultants and CRO statisticians working on the assigned studies.
• supports the Program or Product Statistician in study design to meet project objectives and regulatory requirements
• Develops or oversees the Statistical Analysis Plans (SAPs) and study-level statistical deliverables.
• Provides statistical input to study protocols, CRFs TFL shells or prototypes.
• Ensures that study result interpretation, presentations and CSR conclusions are scientifically justified by the study results.
• Provides programming support for in-house reporting, simulations and exploratory analyses as appropriate.
• Contributes to CSRs, regulatory question responses, publications and abstracts.
• Stays informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings.

The Program Statistician:

• supports the Product Statistician in study design for the program or indication to meet project objectives and regulatory requirements
• is responsible for the overall quality and the timely delivery of the statistical analyses for the studies within the assigned indication or program in compliance with Sobi SOPs and regulatory requirements/guidelines
• Provides statistical and strategic input into the design and preparation of Clinical Development Plan for the assigned program, ensuring alignment with TPPs and Target Label.
• Contributes to regulatory submission documents for the assigned indications, including eCTD content, responses to regulatory questions and other relevant documents.
• provides leadership and project coordination to the statisticians working in the program, including in-house consultants and statisticians at CROs

Scope of the Job

Study Statistician:

• provides leadership to in-house consultants and CRO statisticians working on the assigned studies.
• supports the Program or Product Statistician in study design to meet project objectives and regulatory requirements
• Develops Statistical Analysis Plans and study-level statistical deliverables.
• Provides statistical input to study protocols, Statistical Analysis Plans, CRFs and TFL shells or prototypes.
• Ensures that study result interpretation, presentations and CSR conclusions are scientifically justified by the study results.
• Provides programming support for in-house reporting, simulations and exploratory analyses as appropriate.
• Contributes to CSRs, regulatory question responses, publications and abstracts as delegated.
• Contributes to CRO evaluation, best-practice development, new initiatives and SOP development as relevant.
• Stays informed of developments in new statistical methodology and statistically related guidelines and regulations through literature review and attendance at workshops and professional meetings.

Program Statistician:

• Provide leadership and project coordination to the statisticians working in the program, including in-house consultants and statisticians at CRO
• Provide statistical and strategic input into the design and preparation of the Clinical Development Plan (CDP) for the assigned program ensuring alignment with the TPPs and Target Label
• Provide statistical and strategic input to relevant regulatory documents for the assigned program, e.g. eCTD responses to regulatory questions.
• Provide statistical and strategic input into other regulatory documentation for the assigned program e.g., IB, PSUR and RMP
• Take a pro-active role in designing innovative studies and programs, including Go/No Go criterion and associated risk levels, to meet project objectives
• Contribute to the writing of publications and abstracts, in accordance with the publication strategy for the project
• 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

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:

• Minimum of 5 years of experience as a statistician in the pharmaceutical industry, CRO or related field.
• Previous experience of working as a study statistician or equivalent
• Experience working in more than one phase of clinical development
• Experience of statistical programming in SAS; experience with R or other statistical software is desirable.

Desired:

• Experience of regulatory submission and defense activities
• Experience of regulatory interactions
• Experience of clinical program and study design and data analysis in using a variety of designs and statistical techniques
• Experience of collaboration with statisticians and other functions at CROs in the area of out-sourced 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.

Desired:

• Good understanding of CDISC, including SDTM and ADaM

Personal Attributes

Required:

• Excellent written and oral communication skills
• Strategic thinking and influencing skills
• Ability to communicate statistical information to non-statisticians
• Strong ability to collaborate and contribute in global cross-functional teams
• Leadership skills

Languages

Required:

• Excellent writing and oral communication in English