The Head, Biostatistics will have the overall responsibility and accountability of Biostatistics across all studies in all Phases of development.
This person will provide statistical input into Phase I - IV clinical trial development. This position is responsible to ensure that all Biostatistics activities are conducted in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm’ s commitment to sponsor’s requirements and timelines.
More specifically, the Head of Biostatistics must :
Inspire, lead and develop all functions within Clinical Biostatistics (CB) by formulating a clear vision for the future and attracting and retaining top talent
Ensure appropriate statistical designs, data collection and analysis tools and processes to clearly and robustly address the objectives of clinical studies and programs.
Influence and provide good-faith challenge to the broader clinical organization with respect to clinical development decisions and data interpretation.
Lead development and optimization of CB 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 creative and flexible sourcing strategies to meet the evolving demands of the company when required and to have a vision to build and organize a team of biostatisticians and statistical programmers internally (Head office) that would be supported by a team located in other countries.
Lead a framework in close collaboration with functional heads, in which CB standards (CRF, TLF, 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 designated.
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.
Help in determining CB budget.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and / or have received adequate training.
BSc or Master’s degree in Statistics, Biostatistics, or a related field, plus at least 15 years of clinical development and analysis and reporting experience within the biotech / pharmaceutical or CRO industry.
Minimum of 5 years senior management responsibility leading through others.
Demonstrated success providing statistical programming leadership via direct reports.
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 ICH guidelines, EMEA regulations, CDISC standards / implementation guides, 21 CFR Part 11, and familiarity with 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 statistical software.
Entrepreneurial 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.
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.
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 regulatory submissions.
Ability to make tough decisions to drive the right business outcome.
Seeks win-win but able to stand ground when necessary.
Dynamic self-starter and agile learner.
Ability to balance appropriate levels of structure / process with efficiency and simplicity.
Willingness and ability to travel domestically or internationally as required.
Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations / guidelines.