Senior Statistical Scientist

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

Additional Information