Détails du poste : Associate Director, Biostatistics
Director, Biostatistics will have the overall responsibility and accountability
of Biostatistics and across all studies in all Phases of development.
- Inspire, lead and develop all
functions within Biostatistics by helping formulating a clear vision for
the future and attracting and retaining top talent
- Ensure appropriate statistical designs
and analysis tools and processes to clearly and robustly address the
objectives of clinical studies and programs.
- Assist influencing and providing
good-faith challenge to the broader clinical organization with respect to
clinical development decisions and data interpretation.
- Lead development and optimization of Biostatistics
processes with specific focus on efficiency and quality, while maintaining
or exceeding industry best practices.
- Actively stay abreast of current
industry analysis and reporting trends and practices.
- Evaluate and implement innovative
study designs and novel statistical methodologies as appropriate across
each of the indications in dermatology.
- Provide leadership in development of
creating and flexible sourcing strategies to meet the evolving demands of
the company when required.
- Lead a framework in close
collaboration with functional heads, in which Biostatistics standards
(CRF, TFL, programming standards, CDISC) can be developed, approved
(including change control) and archived appropriately.
- Provide oversight of technical and
executional issues related to Innovaderm studies including knowledge transfer,
facilitation of alignment around processes and deliverables that support
regulatory submissions for our clients.
- Serve as a member of the Protocol
Review, Safety Review, as well as other governance committees as
- Serve as a Biostatistics subject
matter expert to the clinical and projects teams as appropriate; Liaise
with clients regarding the conduct of statistical methodology, data
analysis and interpretation, and regulatory issues.
- Provide statistical support of the
strategic planning, authoring, and review of manuscripts and other
scientific data disclosures.
- Serve as Innovaderm’s representative
to represent function at regulatory meetings, inspections/audits, and
Company partnerships both internal and external.
- Liaise with other company functions
leaders to influence, shape, and drive unified strategies related to
integrated clinical research data, rapid hypothesis generation and other
relevant enterprise efforts.
- Serve as an expert in structuring
algorithms for risk based and centralized monitoring.
degree in Statistics, Mathematics, or related field; Ph.D. preferred.
- Minimum of 12 years of clinical
development and analysis and reporting experience within the
biotech/pharmaceutical or CRO industry.
- Minimum of 2 years senior management
responsibility leading through others.
- Demonstrated success providing
statistical, data management and programming leadership via direct
- Experience in regulatory interactions
and submissions across multiple regions.
- Leadership/participation in industry
organizations including subject knowledge and working groups.
- Experience developing strategies in
collaboration with other cross-functional leaders
- Extensive knowledge of GCP, ICH
guidelines, FDA regulations, CDISC standards/implementation guides, 21 CFR
Part 11, and familiarity with EMA/CHMP regulations and guidelines, and
other international regulatory requirements; In-depth knowledge of the
global drug development process.
- Advanced proficiency in Base SAS, SAS
Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS and other relevant
leadership with the ability to build consensus in a cross functional
environment. Significant ability to creatively solve problems in a
cross-functional setting. Ability to relate to varied level audiences across
the organization. Demonstrated ability to effectively collaborate and influence
throughout multiple levels of the organization.
- Ability to create and develop
high-performing teams; coach and develop team members.
- Excellent oral, written,
communication, and listening skills
- Ability to develop and drive strategy
in complex organizational environments
- Prior experience shaping integrated
strategies related to data collection, integration, and analysis with a
goal to promote rapid hypothesis generation, testing, and decision making
is highly desirable.
- Ability to make statistical concepts
understandable to non-subject matter experts.
- Comprehensive knowledge of issues
surrounding analysis and reporting of clinical trials data.
- Solid knowledge of process surrounding
- Ability to make tough decisions to
drive the right business outcome.
- Seeks win-win but able to stand ground
- Dynamic self-starter and agile
- Ability to balance appropriate levels
of structure/process with efficiency and simplicity.
- Knowledge of ICH/EMEA/FDA guidelines.
- Willingness and ability to travel
domestically or internationally as required.
- Publication record within the
statistical or medical literature
We thank you for your application and please note that only those selected for an interview will be contacted.
Innovaderm only accepts applicants with a work permit for Canada.