Associate Director Biostatistics
The Associate Director, Biostatistics is responsible to 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. Collaborates 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.
- Performs sample size and power calculations
- Reviews Case Report Forms (CRFs/eCRFs)
- Develops Statistical Analysis Plan (SAP) and creates table, listing, and figure shells
- Performs statistical analysis as defined in the SAPs
- Codes complex statistical analyses using good coding practices
- Applies sound statistical methods to various study designs
- Interprets results and writes sections of documents; presents results
- Provides statistical analyses for decision making, regulatory submissions and interactions with regulatory agencies
- Collaborates effectively with clinical investigators on multiple ongoing projects
- Keeps up to date with Medical/Clinical literature as it as applicable to projects
- Develops and assists in maintenance of department tools, templates, guidelines, SOPs, and systems
- Provides statistical input into other teams’ activities and participates in interdepartmental processes
- Other duties as assigned
- Advanced degree preferred, Master's or PhD. An equivalent combination of relevant education and applicable job experience may be considered
- Minimum of 7 years’ progressively responsible experience in clinical research with a focus on biostatistics
- Desirable experience includes prior role as a statistician on clinical trials and/or clinical research projects that have delivered the agreed-upon end products on time
- Pharmaceutical proven experience desired
- 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; familiar 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
- Skilled at presenting information in a clear, concise manner to all levels within the department
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.
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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.
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