Director, Biostatistics - Rare Disease

Please note that this position is based in either San Diego, CA, or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Find out more about this role by reading the information below, then apply to be considered.

Responsible for overseeing the design, execution and interpretation of statistical analyses for clinical trials focused on rare disease.

Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.

Provide statistical expertise and strategic guidance to ensure successful development and regulatory approval of novel therapies.

Primary Responsibilities

• Leads the design and planning of statistical methodologies for clinical trials including
• Sample size and power calculations
• Randomization
• Data collection strategies / CRF review
• Review and / or development of protocol, statistical analysis plan and other related study documents
• Consideration of unique characteristics of rare diseases and specific regulatory requirements.
• Oversees implementation of statistical analyses, including data monitoring, programming and complex modeling.
• Summarizes and interprets results and provides meaningful insights for decision making, risk assessment and regulatory submissions.
• Maintain thorough understanding of current regulatory guidelines and requirements relevant to rare disease drug development.
• Collaborates closely and effectively with R&D teams as well as external partners throughout the drug development process.
• Stay current with advancements in statistical methodologies and rare disease research. Applies sound and innovative statistical methods to various study designs to drive continuous improvement in clinical trial practice.
• Provides oversight and management of internal and / or external statistical staff and assists in planning of resources.
• Develops and assists in maintenance of department tools, templates, guidelines, SOPs, and systems.
• Provides statistical input into other disciplines' activities and participates in interdepartmental processes.
• Other duties as assigned.

Education / Experience / Skills

Ph.D. in Statistics, Biostatistics or a related field. Targeting 10 years of experience as lead statistician on clinical trials in the pharmaceutical industry with significant experience in rare disease drug development.

An equivalent combination of relevant education and experience may be considered.

Solid knowledge of Statistical Analysis System (SAS) programming and knowledge of statistical software (e.g., R, S-Plus, nQuery, EAST).

Experience in programming complex statistical analyses.

• Extensive working knowledge of FDA regulations, ICH GCP guidelines, and the drug development process. Prior regulatory experience with rare disease drug approval is preferred.
• Strong knowledge of statistical methodologies and clinical trial design, experience with adaptive trial design and Bayesian methodologies is a plus.
• Solid command of the English language and excellent verbal and written communication skills and skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
• Ability to consistently demonstrate leadership qualities and ability to manage project responsibilities independently across a variety of different projects;

objectively evaluate situations and make recommendations to meet project goals.

• Excellent interpersonal and networking skills with the ability to build cross functional relationships.
• Prior CRO / statistical team management experience.

Physical Requirements

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 and independently from remote locations.

Employee must occasionally lift and / or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

What we offer you (US-Based Employees) :

• 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 (US-Based Employees) : 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.

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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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