Director of Biostatistics – Clinical Development
Location: Headquarters - Berkeley, CA
Reports to: CMO
Summary & Scope of Position:
This position is responsible for the strategy, planning and implementation of all statistical, programming, and data management functions for the development of products sponsored by Aduro. This position is responsible for providing statistical, programming, and data management input on protocol development, study design, statistical analysis plans, database development, data review, and data analysis, and will interface with CRO resources. This position also provides support to Regulatory, Research, Manufacturing, Business Development, and other areas where biostatistical expertise is required. The successful candidate must have proven technical skills and have demonstrated both strong leadership and highly collaborative abilities.
- Provide strategic leadership to the development and maintenance of the biostatistics, programming, and data management functions within Aduro
- Supervise the biostatistics, programming, and data management staff, including assignments, staffing requirements, prioritization, and budgets.
- Define, establish, and document procedures and policies for the biostatistics, programming, and data management departments within Clinical Development, including staffing requirements and budgets
- Provide statistical expertise and leadership to the development and approval of research compounds, including presenting, negotiating, and defending these results with worldwide regulatory agencies
- Contribute to the preparation and review of clinical protocols and statistical analysis plans (SAP) by developing statistical methodology and writing statistical sections including trial design, sample size and power estimates and describing the procedures to be used to analyze the clinical trial for a final clinical study report
- Co-author clinical study reports, abstracts, publications, manuscripts, and posters, ensuring that statistical results are accurately interpreted
- Interact with FDA, EMA, and other regulatory agencies as appropriate in statistical and programming aspects of study design and data analysis
- Collaborate with team to develop standard operating procedures (SOPs) and processes for critical biostatistics, data management, and programming activities
- Supervise statistical services outsourced to contract research organizations (CROs), independent contractors, and other vendors
- Contribute to clinical development programs and project teams, including input into strategic study design and planning
- Develop and implement standards for biostatistics, programming, and data management functions including production metrics, protocol statistical sections, SAPs, CRFs, analysis tables, figures, and listings
- Relevant early phase oncology and/or immuno-oncology experience required
- Demonstrated strategic and critical thinking
- Excellent communication skills (verbal and written) and excellent organizational skills
- Detail oriented with a dedication to quality and reliability
- Demonstrated sense of urgency and accountability for both individual and team-owned work products, with the ability to work on multiple tasks in a fast-paced, entrepreneurial environment
- Thorough knowledge of FDA and worldwide regulatory requirements and ICH/GCP guidelines
- Ten or more years relevant experience managing a biostatistics group within clinical research in the pharmaceutical, biotechnology, or CRO industry, preferably with oncology products
- MS or Ph.D in biostatistics or statistics, or equivalent
Aduro Biotech, Inc. is at the forefront of discovery, development and commercialization of breakthrough immunotherapies, alone or in combination that make transformative advances in the treatment of challenging diseases. We provide a workplace where employees excel, thrive and deliver value to patients, their families and our partners. Aduro is located in Berkeley, California.
Aduro Biotech, Inc. offers a competitive salary and benefits package. Qualified candidates should forward a resume and cover letter including a statement of interest, availability, and experience in Word or PDF format to: firstname.lastname@example.org PLEASE, NO PHONE CALLS.
Aduro Biotech, Inc. is an Equal Opportunity Employer