DIRECTOR - SR. DIRECTOR, BIOSTATISTICS
Build and manage an efficient biostatistics department to sup****t the
discovery, clinical development and regulatory needs of company. This
position will be responsible for planning and performing statistical
analysis for clinical trials, which includes the design,
implementation, analysis and re****ting of clinical trials. Participate
in the preparation of INDs, NDAs, and other re****ts required by
management and regulatory agencies for drug programs. Hire, train and
manage staff of this new statistical department.
Respond to queries posed by senior management and regulatory agencies.
Responsible for providing statistical advice to clinical research, data
management, and regulatory staff.
Provide vision, management and technical expertise to build a core
statistics and data management function capable of sup****ting discovery
and clinical development. Ensure that company has the necessary
capabilities and staff to operate a core in-house statistical function
and effectively integrate all outsourced data by effectively bringing
the entire function in-house.
This position will provide statistical, clinical trial methodological,
and regulatory input to study teams: trial design, sample size
estimation, randomization, and statistical methods. Responsible for
the analysis of clinical trial data, provide statistical input into the
re****ting of clinical trial results, and clearly communicate
statistical results and concepts to non-statisticians.
Contribute ideas for more efficient and effective design and analysis
of the clinical trials. Appoint, hire, train and manage all department
staff by setting clearly defined goals, timelines, and reviewing the
progress.
Qualifications:
Ph.D. in Statistics / Biostatistics with 5-10 years of related
experience working in various therapeutic areas and all phases of
clinical development. Some experience with SAS programming /
databases is a plus.
Position requires excellent and proven leader****p skills, team building
skills, and exceptional written and oral communication skills. Strong
ability to handle multiple projects simultaneously. Capable of
representing the Company in statistical discussions with the FDA and
other major regulatory authorities worldwide.
Company offers an exciting, cutting-edge work environment, the
op****tunity to build this new department from the ground up,
competitive compensation package and full relocation package to San
Diego.
Please email resume in MS WORD format to: Resumes@[EMAIL PROTECTED]
Staffing Services, Inc.
Elite Recruiting Services, Inc.
Web: www.elitestaffingsvc.com
Phone: 858-455-8300
Fax: 858-455-8383
|
