Director, Biostatistics

Systimmune•Redmond, WA

17d•$200,000 - $250,000•Onsite

About The Position

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. Director of Biostatistics provides scientific and statistical leadership for assigned clinical development projects. A highly empowered, visible and collaborative role, the Director works in partnership with clinical and regulatory experts to advance medicines to our patients. This position will require an onsite presence in our Redmond, WA or Princeton, NJ offices.

Requirements

MS (with 13+ years of experience) or PhD (with 9+ years of experience) in Statistics, Biostatistics, or a highly related field.
High degree of technical competence and excellent communication skills, both oral and written.
Successfully led Phase III regulatory submissions to FDA, EMA, NMPA, PMDA, etc.
Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
Able to build strong relationships with peers and cross-functional partners to achieve higher performance.
Highly motivated to drive innovation by raising the bar and challenging the status quo.
Possess strong leadership & project skills and experience in working/managing cross-cultural or global teams.
Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
Extensive end-to-end (from conception of protocols to successful regulatory submission/approval) oncology and/or hematology drug development experiences as indications or compound lead.
Passionate about finding fit-for-purpose solutions to overcome challenges encountered in oncology drug development.

Responsibilities

Lead the statistical support for one or more clinical development projects through own efforts or those of a team.
Lead statistical strategy for project development and regulatory submission.
Direct and review the development of design, analysis and reporting for clinical or other scientific research programs.
Review protocols, statistical analysis plans, and statistical programing plans.
Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management.
Partner with other functions (Clinical, Regulatory, or Safety) to create development strategies for assigned projects.
Represent Biostatistics and Data Science on data monitoring committees.
Build interdepartmental relationships.
Demonstrate extensive understanding of statistical concepts and methodology.
Propose novel statistical methodological approaches to design of scientific studies.
Provide sufficient detail to allow programming implementation.
Ensure that all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately.
Lead strategy and direct development and implementation of project-specific database-related activities in collaboration with Data Sciences, Statistical Programming and other stakeholders.
Train and mentor staff on statistical methodology and operations.
May supervise a group of statisticians as a people manager.
Gain expertise in innovative statistical methods.
Assist functional leaders in recruiting qualified personnel and arranging training opportunities for professional development of staff.
Develop strategy for data presentation and inference.
Ensure appropriate interpretation of statistical deliverables in collaboration with other functions.
Collaborate in publication of scientific research.
Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
Act as the liaison for statistical issues on the company collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing activities.
Build external scientific connections which foster professional development and promote the reputation of the Statistics department.
Ensure that all applicable regulatory requirements for work processes are met.
Critically review regulatory submission documents.
Represent Biostatistics and Data Science in discussions with regulatory agencies and on Advisory Committees.

Benefits

SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

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