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
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