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Director, Statistics
(Ref # DSTAT0810RM)
The successful candidate will work collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for statistical data analysis and reporting.
Primary duties will include:
- Providing statistical consultation on trial design and study endpoints.
- Calculating sample sizes and authors statistical analysis plans.
- Utilizing knowledge of Regulatory requirements and guidance documents to provide statistical advice with respect to creating a clinical development program.
- Using knowledge of literature to provide data analysis and presentation methods to support publications/presentations.
The candidate will have five (5) to ten (10) years pharmaceutical industry experience to include lead statistical role(s) in establishment of Phase III program(s), oversight of clinical study reports, support for NDA submission, and publications. Scientific programming capability with statistical software packages is a must.
Ph.D. / Masters required.
Apply Here Send Job to a FriendClinical Project Manager
(Ref # CPM0810RM)
The successful candidate will be responsible for ensuring that the clinical programs for ACADIA projects are executed effectively. This will include oversight, management and guidance of clinical trials. A component of the role will be to ensure quality of delivery of goals within agreed budgets and timelines. The candidate will be required to work with project leaders to ensure that appropriate resources and information are available in order that project goals are met. It will be necessary for that person to have experience in developing protocols, SOP’s, Clinical Study Reports, and other documents to support an NDA.
The candidate will possess well-developed skills to select CRO’s and manage these external resources effectively.
Ten (10) years of relevant clinical experience in the pharmaceutical industry, or equivalent, to include:
Primary duties will include:
- Experience managing staff as well as mentoring and developing junior staff.
- Excellent interpersonal skills.
- Demonstrated ability to lead.
- Strong communication skills and the ability to create a clear sense of direction.
- Knowledge and understanding of GCP and other Clinical Trial Regulations and guidelines.
- Demonstrated ability to successfully develop, implement, manage and complete clinical trials.
College degree required; Master’s degree preferred.
Apply Here Send Job to a FriendACADIA Pharmaceuticals Inc. offers a competitive compensation and benefits package, including medical, dental, vision, life, long-term and short-term disability, flex spending accounts and 401K match. Please submit your resume to hr@acadia-pharm.com for consideration.