Head of Biometrics
The Head of Biometrics will be a member of the R&D leadership team and will be a significant contributor to the overall R&D strategy at Replimune, and reporting to the Chief Medical Officer. The Head of Biometrics will serve as a strategic partner with Clinical Development, Regulatory Affairs, Medical Affairs and Clinical Operations to provide drug development leadership on the design and execution of robust clinical development plans. This role develops overall strategy of data acquisition and processing, plays a critical role in the design of new clinical programs and trials, ensures that appropriate statistical approaches for the design and analysis of clinical studies are employed and ensures the adequate interpretation and presentation of results, and plays a key role with regulatory submissions and interaction with global health authorities.
- Lead the Biometrics function with clarity of vision and purpose, provide leadership and oversight for all aspects of the function, facilitate knowledge sharing and creation, and improve overall quality and processes.
- Overall accountability for the biostatistics, data management and statistical/clinical programming strategy and execution, including instruction and oversight of vendors.
- Leads and develops the Biometrics statisticians, applications programmers and supervises the head of the Data Management team; supervises hiring of team members and conducts development.
- Provide strategic and operational statistical expertise for early through late stage clinical development programs.
- Involved with all statistical facets of the clinical programs, including Phase 1-3 trials progressing to marketing authorizations and responsible for corresponding sections in regulatory documents e,g. IND submission, IND annual updates, briefing documents, study protocols, investigator brochures and other study-relevant documents.
- Provide guidance and expertise to the clinical development team regarding biometrics related subject matter.
- Leads input on design of study, including outcome measures, endpoint assessment, and sample size/power calculations, reviews protocols, and database requirements.
- Conceives and writes or guides the drafting and review of the study level documents e.g. SAP and statistical methods sections for clinical trial and research protocols, TLF templates.
- Oversees statistical programming and database management personnel involved in clinical data processing, including case report form design, data tracking, data entry codes and document processing.
- Ensures that data standards are prospectively managed according to consistent predefined data elements. Estimates statistical and programming time requirements for team timelines. Validates standard programs and macros written by other programmers.
- Contributes to the discussion and drafting of Program documents e.g. the clinical development plan, SIP (Statistical Integration Plans) and the integration of results from entire programs (ISE, ISS, ISI).
- Ensures necessary SOPs are developed or updated to support the quality and timeliness of team deliverables.
- Represent the company at health authority meetings (e.g. FDA/EMA), and Advisory board meetings.
- Support preparations for interactions with regulatory agencies and provide strategic guidance to ensure high quality preparation of Regulatory Authority documents (clinical study reports, submissions, clinical protocols, safety reports, etc.). Serve as the lead responsible to providing analysis to regulatory queries.
- Ensure credible communication of clinical trial data internally and to Health Authorities, the academic community, and healthcare providers, as appropriate
- Ensure that the interpretation of data obtained from our trials, from trials conducted by our collaboration partners, CROs and competitive data is accurate, scientifically sound and credible
- Oversee the continued optimization of state-of-the-art, best practice systems for programming
- Prepares statistical reports, tabulations, and graphs for presentation at meetings or conferences, and for publication in technical journals.
- Provide statistical support to non-clinical areas.
- Participate in vendor evaluation/selection and oversight
- Stay abreast of emerging technologies and concepts related to applied statistical methodology
- Lead change in the organization to continuously adapt to a dynamic and high growth environment while applying learned knowledge to enhance organizational performance
- Engage and energize employees through communication of goals, priorities and other business critical information as well as focus on employee development and retention activities
- PhD or equivalent in Statistics, Biostatistics or related discipline required.
Experience and Skill Requirements:
- 10-15+ years of leadership experience of a biometrics department in the biotech/pharmaceutical industry.
- Experience in oncology required and specifically in immuno-oncology preferred.
- Hands-on knowledge of clinical trial principles, design and analysis with a background in applying statistical methods to all phases of clinical trials.
- Extensive knowledge of clinical trial development and statistical methodology related to trial design and conduct of clinical studies is required
- Knowledge and expertise in multiple design and executions strategies
- Scientific background and understanding of clinical trials, clinical development operations and regulatory compliance
- Leadership experience with proven capability as a successful leader in a strategic multifunctional environment, highly skilled in leading change and people agility
- Extensive knowledge of ICH, FDA, and GCP regulations and guidelines; well-rounded technical skills, CDISC ADAM and SDTM data models.
- Strong business acumen and critical thinking
- Ability to work closely with clinical leaders to maximize study designs
- Strong mentoring abilities to build and develop statistical and programming talent
- Experience working with statistical programming groups to maximize efficiency
- Strong programming, analytical, verbal, written communication.
- Extensive experience negotiating successfully with health authorities
- Strategic and critical thinking to support leadership decisions and drive direction of development strategy
- Strong leadership and management skills, and ability to effectively lead and collaborate with various business functions
- High attention to detail including proven ability to manage multiple, competing priorities
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.