K2
Executive Search
Priniciplal Biostatistician
The
Principal Biostatistician is responsible for leading the planning,
statistical analysis and reporting for assigned clinical /
non-clinical projects. In collaboration with project team members,
evaluates statistical design of studies including sizing; writes
statistical analysis plans and statistical sections of protocols;
reviews protocols, case report forms, data management plans, sample
size estimates, randomization schedules, clinical study reports and
sections of regulatory submissions; and performs statistical analysis
in support of product regulatory submissions. Assures acceptability
and scientific integrity of data collection and analysis through
appropriate application of statistical principles and methodology,
and is able to argue logically in support of study results and
conclusions. Functions at discretionary level of autonomy as deemed
appropriate by Director of Regulatory Affairs.
Subject
to approval of Director of RA, develops statistical analysis
strategies and selects appropriate methodologies for research studies
involving pharmaceuticals, contrast imaging agents, and medical
devices. Applies statistical theory and analysis methods to data to
ensure a sound scientific basis for product performance claims.
ESSENTIAL
FUNCTIONS
1.
Responsible for sample size determination, power calculations, and
randomization.
2.
Provides statistical expertise in the development of scientifically
sound study protocols for Phase I - IV clinical studies.
3.
Participates in the design, development, and approval of case report
forms.
4.
Writes statistical sections of protocols and statistical analysis
plans.
5.
Follows FDA, EMEA, and ICH regulations/guidelines for the conduct of
statistical design, analysis, and reporting for clinical studies of
pharmaceuticals, imaging agents, and devices.
6.
Develops and/or modifies SAS programs in a Windows environment.
7.
Performs literature searches to support study design and sizing.
8.
Performs statistical analyses; summarizes, interprets, and
communicates analysis results and conclusions both verbally and in
writing to scientists, clinical researchers, regulatory affairs
personnel, and medical writers.
9.
Provides statistical expertise relative to post-market surveillance,
product vigilance, R&D, and QA.
10.
Provides statistical expertise in the design, conduct, and analysis
of bioequivalence, bioavailability, and pharmacokinetic studies.
11.
Provides statistical training to personnel both within and outside of
Biostatistics
12.
Coordinates activities of other Biostatistics staff members and
external consultants.
13.
Assists the Director of RA in choosing and implementing statistical
standards and processes for the department.
REQUIREMENTS
Education
required/ preferred: MS/MA and/or PhD in Biostatistics/Statistics
(PhD preferred) with industry experience preferred.
-Experience:
5 years (PhD) or 8 years (MS/MA) full-time experience in the design,
analysis, and reporting of clinical trials for regulatory
submissions. Participation in meetings with regulatory
authorities
-Preferred
Skills/Qualifications: Presentation skills and comfort with
presentations to non-statistical audiences. High degree of knowledge
about and proficiency in SAS programming. : Well grounded and
knowledgeable in current statistical theory and methods as applied to
Phase I-IV drug clinical trials as well as in general statistical
methods used in biological/medical research..
Technical/scientifically oriented individual. Ability to handle
multiple competing projects and deadlines. Knowledgeable of FDA,
EMEA, and ICH guidance relevant to clinical trials, particularly,
statistical guidance
-Other
Skills: Knowledge of SQL or willingness to learn. Familiarity with
other statistical software such as nQuery, WinBUGs, R.
EVERYTHING ELSE
$90-110K + relocation to family friendly Midwestern location + comprehensive benefits package
David Ruyle
888-282-5520