Senior Director, Biostatistics (24206-U-615-MED)
Remote
Medical Sciences /
Full-Time /
Remote
WHO WE ARE
Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Senior Manager, Quality Control to work onsite based in our Hayward office.
ArsenalBio’s mission and purpose is very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines with the goal to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.
Driven by a collective of diverse experts across multi-scientific disciplines as well as clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients’ lives.
This means you’ll have the opportunity to work with the best talent in the field of cell therapy, and be part of ONE TEAM advancing therapies for patients who need it most.
We are investigating our cell therapies in cancer patients in clinical trials and need a statistical lead to join our Biometrics team. In this role, you will serve as the subject matter expert for statistical methodologies. In addition you will contribute to clinical and diagnostic development strategies by designing clinical trials that utilize real-world evidence, developing biomarker analysis strategies, interpreting and communicating analysis results, and managing CROs.
WHAT YOU’LL DO
- Lead statistical activities of ArsenalBio cell therapy programs, including statistical input to develop efficient dose optimization strategies for first-in-human trials, innovative designs, and develop RWE/RWD strategies for regulatory submissions
- Collaborate with translational science and clinical teams to develop Biomarker Data Analysis Plans and perform exploratory analyses
- Contribute to the development of companion diagnostic strategies for existing and upcoming ArsenalBio programs
- Lead and conduct statistical modeling and simulations to enable innovative and optimal statistical designs and to address identified or potential statistical issues arising in programs or studies
- Work in tandem with ArsenalBio internal biometrics team to establish analysis standardizations (eg, TFL shells, provides guidance to statistical programmers on ADaM specs, programming specifications for statistical models, and data consistency standards)
- Participate in data deliverable timeline planning to support overall clinical development strategies for ArsenalBio cell therapies.
- Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles
- Develop innovative integrated evidence strategies for ArsenalBio clinical programs in collaboration with internal and external teams to ensure statistical and scientific rigor in design and analyses
- Author statistical analysis plans for clinical trials and integrated summaries of safety/effectiveness (ISS/ISE).
- Review case report forms (CRFs) and EDC database designs to ensure data collection meet the requirements of statistical analyses
- Provide statistical input to Safety Review Committee and Data Monitoring Committee meetings
- Oversee statistical vendors in collaboration with ArsenalBio biometrics team to conduct milestone data deliverables and final database lock
- Serve as a mentor to junior team members as applicable
WHO YOU ARE
- Masters degree in statistics or biostatistics with 15+ years of experience in the pharmaceutical/biotech industry. Ph.D. with 12+ years preferred
- In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches
- Familiar with ICH E9 and E9 (R1) and the implementation of Good Clinical Practice (GCP)
- Proficient in statistical programming (SAS and R)
- Ability to use statistical simulations to account for uncertainty and in scenario planning for study design and analyses.
- FDA or EU oncology filing experience preferred
- Familiar with regulatory statistical requirements for oncology clinical endpoints
- Knowledge and experience in working with clinical data, imaging data, molecular/sequencing data, and biomarker data.
- Familiar with CDISC standards
- Excellent problem solving, analytical and organizational skills
- Strong verbal and written communication skills, allowing for open and effective dialogue throughout the company and with business partners
- Successful collaborative and team effectiveness skills in working with colleagues in other technical disciplines
- Preferred qualifications: Experience with cell and gene therapies are desirable
$0 - $0 a year
BENEFITS AND PAY
ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge.
Our people-first culture fosters a deep appreciation for humanity, both in the people we endeavor to serve as well as each other. We are proud to work for a company that is driven by diversity in experiences, ideas and interests, and one that empowers us in an environment that embraces both unity and inclusivity.
We have robust tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as our people are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.
We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
The estimated base salary for the preferred primary location of the San Francisco Bay area ranges from $224,500 – $275,000. Salary ranges for other locations may vary. Base pay offered may vary based on job related knowledge, experience, education, and location. In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.
To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.
