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
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
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
Ph.D. or MS in Statistics, Biostatistics or equivalent
15+ years of Biostatistics experience in a drug-development
8+ years of managing experience in a drug-development
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
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
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.
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.
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
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
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