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Director, Biostatistics

Company: Avanir Pharmaceuticals Inc.
Location: Aliso Viejo
Posted on: September 12, 2020

Job Description:

The Director, Biostatistics will require experience in statistics, drug development, and clinical research. The Director, Biostatistics is expected to work collaboratively with the R&D department to determine accurate study designs, sample size estimates, and write sections of study protocols. Essential Job Functions:

Determines strategy and delivers results with core member of scientific teams in a timely and high-quality environment.

Lead and drive enhanced quantitative drug discovery and development to bring innovative statistical thinking and methods to be utilized in clinical programs. Central to this approach is the systematic review of prior information, statistical model building and simulation, utilizing different statistical methods as appropriate, to design more effective studies.

Participate in study design and protocol development and ensure that study designs are consistent with study objectives and are optimal within study constraints.

Calculate sample sizes and/or perform power calculations for proposed studies as well as for alternative designs to evaluate the costs and timing for various scenarios.

Propose methods for statistical analysis and write the statistical section of study protocols.

Knowledgeable about current important statistical issues in clinical trial study design.

Review and consult on CRF design and database edit checks in addition to reviewing programming plans.

Prepare randomization schedules.

Prepare/review statistical analysis plans, specifications for analysis datasets, and table shells. Ensure that tables, listings, and graphs address the objectives of the study.

Perform statistical analyses of clinical data using SAS and other statistical software packages as necessary.

Oversee the work of internal programmers and/or CROs that are performing statistical analyses of clinical data.

Lead the study and/or project teams in the review and discussion of statistical analysis plans.

Interpret statistical results and present study findings to the study teams, senior management, and in various external forums.

Maintain project files that ensure adequate and documentation of statistical analyses.

Reporting directly to the Director/Sr. Director, Biostatistics within Avanir R&D Operations Department.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Education/Qualifications:

Ph.D. or MS in Statistics, Biostatistics or equivalent required.

15+ years of Biostatistics experience in a drug-development environment.

8+ years of managing experience in a drug-development environment.

Excellent written and oral communication skills.

Prior experience interacting with health authorities in the United States and/or the EU.

Prior experience with IND/BLA/NDA/MAA submissions.

Experience or training with a range of skills including SAS programming and other relevant software applications, statistical methodology and theories, and analysis.

Experience within a team environment, have strong presentation skills, collaborative skills, negotiation skills and demonstrate self-motivation.

Ability to manage multiple and diverse issues.

Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel.

Experience writing technical and management documents, reports and presentations.

Physical Requirements:

This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver’s license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.

Work Environment:

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.

EEO Statement:

As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination.  Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.

Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.

Posted 30+ Days Ago

Full time

R2040

About Us Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit http://www.avanir.com

Avanir is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en

Avanir® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries

Keywords: Avanir Pharmaceuticals Inc., Aliso Viejo , Director, Biostatistics, Other , Aliso Viejo, California

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