Foster City

POSTION SUMMARY

The statistical lead applies technical expertise and experience to provide written and verbal recommendations on statistical issues, design and conduct of clinical trials of all phases. Uses initiative to develop, maintain and share knowledge of the theory and application of current statistical methods appropriate for data analysis and clinical trial design. Works collaboratively with clinicians, data managers, other biostatisticians, statistical programmers, and medical writers in the planning, conduct and analysis of clinical trials. 

JOB FUNCTIONS/RESPONSIBILITIES

• Works with study team members and generates clinical protocols; authors statistical analysis plans; develops tables, figures, and listings (TFL) templates; reviews specifications, CRFs, and CRF edit checks.
• Performs analyses, interprets study results, and collaborates with clinical team to produce interim reports, final reports, and publications.
• Ensures achievement of statistical deliverables and milestones in coordination with other functions including clinical research, statistical programming, regulatory, data management, and medical writing.
• Collaborates with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation.
• Effectively manages CRO to ensure high-quality deliverables within timeline and budget.
• Responsible for more than one study with concurrent tasks and timelines.
• Participates in the validation/QC of key study endpoint analysis and submission deliverables.
• Applies appropriate regulatory guidelines to the projects.

QUALIFICATIONS

Education/Experience:

• MS/MA degree in related discipline and 3-6 years of related experience; or,
• PhD in related discipline and 2-3 years of related experience, or;
• Equivalent combination of education and experience.

Knowledge, Skills and Abilities:

• Knowledge of appropriate regulations, industry standards and guidance documents.
• Ability to interact effectively with biostatistical, data management, operations and clinical personnel from CROs and companies collaborating with Mirum.
• Develop/review SDTM/ADaM specifications.
• Strong SAS and R programming knowledge preferred.
• Guides the successful completion of major programs, projects and/or functions.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
• Has good general knowledge of other related disciplines.
• Applies strong analytical and business communication skills communicating difficult concepts to non-technical audiences.

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