Associate Director Biostatistics
The Associate Director of Biostatistics will perform a variety of advanced biometrical, statistical, and technical activities for the design, analysis, and interpretation of statistical data in conjunction with a research program based on company products. They will collaborate closely with project teams consisting of clinicians, project managers, programmers, data management, and other team members. Supports (with review) trial planning and analysis activities in support of clinical trials.
- All statistical tasks on assigned trials including Phase I – IV clinical trials
- Establish protocol development in alignment with the development plan, statistical analysis plan, and reporting activities
- Plan, manage, and track biostatistics activities, timelines, and resources and assure operational excellence
- Planning and execution of exploratory analyses and statistical consultation within cross-functional teams
- Collaborate with internal and external partners to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types
- Interact with regulatory agencies and address statistical questions and requests, including clinical investigators
- Review and/or author SOPs and/or Work Instructions related to biostatistics practices
- Contribute to external engagement with consultants, advisory boards, health authorities, congresses, and scientific meetings
- Provides statistical analyses for decision-making, regulatory submissions, and interactions with regulatory agencies
- Collaborates effectively with clinical investigators on multiple ongoing projects
- Provides statistical input into other activities and participates in interdepartmental processes
- Other duties as assigned
Education and Experience
- MS in statistics or related field; PhD preferred. An equivalent combination of relevant education and applicable job experience may be considered
- Targeting 7 years’ progressively responsible experience in clinical research with a focus on biostatistics, preferably in Clinical Research, Biotech, Pharmaceutical industry
- Knowledge and understanding of SAS programming and at least some other significant statistics software (e.g., R, S-Plus, PASS) is a plus
- Ability to code complex statistical analyses, and familiarity with good coding practices
- Solid understanding of FDA regulations, ICH GCP guidelines, and the drug development process
- Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required
- Able to prioritize work and complete deliverables to timelines with some supervision
- Demonstrate knowledge of applying sound statistical methods to various study designs
- Skilled at presenting information in a clear, concise manner to all levels within the department
- Skilled at contributing on a consistent basis to team initiatives in a detailed and timely manner
- Experience in early phase clinical trials is preferred
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.
What we offer you:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
EEO Statement: Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.