Alder Biopharmaceuticals, Inc.
Senior Director, Biostatistics
Alder is revolutionizing the way antibody therapies are identified, selected, developed and produced. Our proprietary technologies make great strides possible in the field of antibody therapeutics, yielding innovative potential new treatments for conditions such as migraine and rheumatoid arthritis.
At Alder we seek talented contributors who thrive in a high-energy team environment and want to make a real and lasting impact in the field of antibody therapeutics. Alder teams are creative, collaborative, open, committed--and central to the success of this company and its mission. If this is the kind of company you want to work for, we want to hear from you.
In this newly created leadership position, the Senior Director, Biostatistics will support drug development activities and decision making encompassing Phase I-IV studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Proven experience in strategic input into clinical development plans, and familiarity with regulatory standards and requirements.
Specific responsibilities will include:
- Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives.
- Provide oversight of statistical and strategic content in support of regulatory interactions.
- Effectively coordinate statistical endeavors with outside organizations, CROs and consultants.
- Identify and implement emerging new ways of doing clinical development and new methodologies.
- Participate in establishment and development of department SOPs.
- Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines.
- Maintain an active role in planning and preparation of regulatory submissions- briefing books and integrated summary documents.
- Contribute to project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Operations management.
- Ph.D. in Statistics or Applied Mathematics. 12+ years of clinical research and drug development experience.
- In-depth knowledge of methodologies applied in clinical trials with focus on registration and life-cycle management.
- Extensive experience of interactions with regulatory agencies- US and Non-US Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development.
- Must be knowledgeable about FDA and EMA data standards and must be able to program in SAS.
- Must have strong communication and interpersonal skills. Flexible to changing priorities, detail-oriented, and works well under pressure.
- Must be able to communicate statistical information to people with no science background.
Please send your cover letter and resume to firstname.lastname@example.org. When applying for this position, please reference job code C16-04 and let us know how you heard about this opportunity.
Alder Biopharmaceuticals, Inc.
Reference Job Code: C16-04
Alder Biopharmaceuticals, Inc. is an Equal Opportunity Employer