The Director, Biostatistics is responsible for leading multiple clinical studies, provides statistical support on study design and all aspects of study conduct, including but not limited to author/review statistics section in the protocol, sample size determination; author/review statistical analysis plan and mock TFL, review study randomization files, ADaM specs, CRF design, DMC charter, analyze and interpret the clinical study results, and ensure statistical integrity.
- Represents Biostatistics function at cross-functional meetings; collaboratively within cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
- Validate the results of key statistical deliverables, including topline TFL, perform ad hoc and exploratory statistical analyses
- Oversight statistical vendors to ensure timeliness and quality of analysis data and statistical outputs
- Provide input to Product Development Team (PDT) and Clinical Development and Regulatory Team (CDRT) and performs statistical function for regulatory submission related activities
- Provides statistical support to other disciplines related to clinical statistics
- Develops department processes and standards and trains department personnel to apply them
- May represent department in meetings with regulatory agencies
- Support publications, including manuscripts, conference presentations and posters
- A PhD in Statistics, Biostatistics, or related field with minimum of 6-8 years clinical trial experience in pharmaceutical or Biotech Company, or MS degree with minimum 10 years’ experience; oncology experience is preferred.
- Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including survival analysis, Bayesian method, missing data imputation, multiplicity adjustment.
- Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concept into layman’s term. Demonstrated leadership skills.
- Proficiency with statistical programming in SAS and/or R.
- Knowledge of CDISC standard including SDTM, ADaM
- Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
Please be advised, inquiries or resumes from recruiters will not be accepted.