Department: Clinical Affairs
Reports to: Chief Medical Officer
Location: Office US-based
Summary of job description:
Reporting into the Chief Medical Officer, the Director of Biostatsitics is a full-time position for an established biostatistician with experience in pre-clinical and clinical trials statistical analysis and modeling. The ideal candidate will provide statistical leadership and will be joining an enthusiastic and growing team of clinicians, scientists and immune-oncology drug development experts. The candidate will provide statistical oversight for clinical protocol development, regulatory interactions, data assessment and assistance with pre-clinical and biomarker immune analyses. This is an opportunity for the ideal candidate to establish a new Biostatistics program within the company and contribute to the drug development strategy at Replimune. Replimune, Inc. is a biotechnology company focused on oncolytic virus drug development for the treatment of cancer. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
- Provides statistical support to assigned clinical trials, scientific projects and programs
- Provides clinical trial statistical analyses and sample size justification assessments, as requested.
- Ability to think critically, develop unique solutions when necessary, and communicate and write analysis approaches
- Provides responses to statistical issues arising in regulatory, quality and compliance, clinical or other legal settings as required
- Builds and maintains strong collaboration with different disciplines across the organization in order to identify and meet their needs for statistical support
- May represent Biostatistics on clinical and pre-clinical project teams as required
- Provides professional statistical support to clinical development teams
- Reviews and provides analysis of safety reporting, biomarker analyses and other aspects of clinical trial monitoring
- Under supervision, able to handle requests from regulatory agencies, local IRB and ethical committees and other health authorities
- Interacts with team members across functional areas and multiple studies as requires
- Ensures timeliness and high quality of Biostatistics deliverables
- Supports staff to resolve statistical or technical issues
- Assists in preparation of clinical trial documents, including clinical protocols, investigator brochures, statistical analysis plans, and other, as needed
- Serves on internal and external committees (i.e., with collaborating partners) to provide statistical perspective
- Assists in the preparation of clinical study reports, scientific abstracts and peer-reviewed manuscripts
- May help review and prepare company presentations to ensure accurate statistical information
- Interact with external collaborators and statistical consultants
- May be asked to serve on Replimune internal committees, as appropriate
- May be asked to serve as a Replimune representative on external committees and foundations, as appropriate
- Master’s degree in Biostatistics/Statistic or equivalent
Experience and skill requirement:
- 2-5 years industry experience is preferred
- Thorough understanding of statistical principles and clinical trial methodology
- Broad knowledge of medical/biological terminology and clinical trial designs and competitive landscape in relevant therapeutic areas
- Able to manage many projects simultaneously, to manage conflicting priorities, and be flexible when priorities change
- Able to handle highly complex tasks with supervision
- Must be able to deal with ambiguity
- Knowledge of the clinical development process and the role of biostatistics
- Able to contribute to development of innovative/creative statistical/technical solutions to complex problems
- Effective team player
- Willingness to go the extra distance to get results, meet deadlines, etc.
- Demonstrates excellent communication skills, strong organizational skills, including the ability to prioritize
- Knowledge of current methodology research and focusing on methodology research driven by project need
- Highly conversant with SAS programming, and detailed knowledge of SAS procedures and other statistical software
- Effective communicator in verbal and written venues
- Attentive to detail
- Able to write and present information effectively
- Knowledge of the drug development process is a plus
- Be a diplomatic professional, ‘clicking’ easily with the company leadership, with diplomatic skills that contribute to becoming a leader in immune-oncology
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.