Reports To (Position): SENIOR DIRECTOR OF BIOSTATISTICS
Location: South San Francisco, CA
Department Name: BIOMETRICS
HR Designations: Pay Status – Exempt
Objective of Position
We have an exciting opportunity for a Senior Manager or Associate Director of Biostatistics, depending on qualifications and experience, based in South San Francisco, CA. This position is to serve as a lead statistician for oncology and hematology studies, and to coordinate activities with other functional groups to ensure timeliness and quality of study deliverables for biostatistics.
Essential Duties/ Responsibilities
- Provide statistical expertise for design, analysis and reporting of clinical or scientific research studies
- Collaborate with Clinical Sciences, regulatory affairs and other functions on protocol development, including choosing an appropriate study design and statistical methodology, defining endpoints, calculating sample size, and writing statistical sections of the protocol.
- Develop statistical analysis plans and analysis specifications.
- Collaborate with statistical programming to ensure that appropriate programs and documentations are being developed for datasets development and outputs generation, and ensure the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.
- Collaborate with data management and clinical operations over the course of trials to provide statistical input to study conducts and database development as well as data collection/cleaning.
- Collaborate with clinical pharmacology and translational medicine group to provide statistical input and support as needed Collaborate in publications, assist in data interpretation, and ensure consistency and accuracy in data presentation
- Interact with medical writing and other functions on regulatory documents containing statistical information and clinical data (e.g. Clinical Study Reports, Summary documents for NDA submissions)
- Contribute to the development of functional-level standards, SOPs, and templates.
- Represent biostatistics on study/project teams.
- Establish and maintain effective working relationships with study/project teams.
- Oncology drug development experience is preferred, though not required.
- Experience with early development studies is desirable.
- Competent in design, descriptive and inferential statistics in clinical trials, biopharmaceutical applications.
- Ability to work within a team and work independently are required.
- Excellent verbal and written communication skills are required.
- Good interpersonal and project management skills are essential.
- Knowledge of SAS and/or R is strongly desirable.
- Ph.D. or M.S. in statistics, biostatistics, or related field with minimum 5 (Ph.D.) – 10 (M.S.) years of experience as biostatistician in the biotech/pharmaceutical industry or medical research.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.