- Perform in a lead Biostatistician role and provide technical expertise as a core team member of high complexity clinical studies, including statistical oversight and attending relevant project meetings
- Provide expert level statistical guidance and thought leadership for innovative study design and clinical development plans, including endpoint selection powering
- Develop the statistical sections of the study protocol for clinical studies
- Responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents
- Conduct overall statistical review of TFLs for clinical studies
- Manage operations work with internal statistical programmers to ensure timeliness and quality of deliverables
- Represent Biostatistics in interactions with regulatory authorities (e.g FDA) and during audits
- Support the preparation of abstracts, oral presentations, manuscripts and written reports by ensuring the results of clinical programs and studies are effectively communicated to internal and external stakeholders
- Provide statistical expertise to internal and external stakeholders (e.g., presentation/publication, Marketing, Health Economics & Reimbursement)
- Create, maintain, and implement SOPs, processes, standards, and work instructions with respect to biostatistics to ensure compliance, accuracy, efficiency, and optimization
Must haves: - Masters degree or higher in Statistics, Biostatistics or Math
- 10+ years of lead project work as a statistician on clinical trial projects
- Expert understanding of related aspects of biostatistics processes and systems
- Excellent written and verbal communication skills including the ability to interact professionally with all organizational levels to drive achievement of deliverables
- Strong interpersonal and relationship management skills including the ability to proactively elevate and resolve issues cross-functional to ensure project objectives are met
- Comprehensive organizational, judgment, analytical, decision-making, and influencing skills
- Proven successful project management leadership skills
- Expert understanding of clinical trial design while identifying applications of functional knowledge and methodologies to resolve complex problems
- Experience leading briefings and technical meetings for internal and external stakeholders
- Ability to develop effective peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
- Ability to thrive in a fast paced, dynamic, and constantly changing work environment
Nice to haves: - PhD degree or higher in Statistics, Biostatistics, or Math
- Experience leading IVD clinical Biostatistics to FDA submission
- Knowledge of CDISC requirements preferred
Benefits and additional information:The US target range of our base salary for new hires is $201,450 - $309,000. You will also be eligible to receive pre-IPO equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company's sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ for additional company information.
Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Applicants have rights under Federal Employment Laws.
- Family & Medical Leave Act (FMLA)
- Equal Employment Opportunity (EEO)
- Employee Polygraph Protection Act (EPPA)
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- Family & Medical Leave Act (FMLA)
Principal Biostatistician - South San Francisco, United States - Freenome
Description
Why join Freenome?
Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages.
Cancer is relentless. This is why Freenome is building the clinical, economic, and operational evidence to drive cancer screening and save lives. Our first screening test is for colorectal cancer (CRC) and advanced adenomas, and it's just the beginning.
Founded in 2014, Freenome has >500 employees and continues to grow to match the scope of our ambitions to provide access to better screening and earlier cancer detection.
At Freenome, we aim to impact patients by empowering everyone to prevent, detect, and treat their disease. This, together with our high-performing culture of respect and cross-collaboration, is what motivates us to make every day count.
Become a Freenomer
Do you have what it takes to be a Freenomer? A "Freenomer" is a determined, mission-driven, results-oriented employee fueled by the opportunity to change the landscape of cancer and make a positive impact on patients' lives. Freenomers bring their diverse experience, expertise, and personal perspective to solve problems and push to achieve what's possible, one breakthrough at a time.
About this opportunity:
We are seeking a Principal Biostatistician to expand the Freenome Biostatistics team. This role will lead statistical study design, analysis, summarization of clinical studies to support research, development and regulatory submissions for Freenome's in vitro diagnostic products (IVDs). The ideal candidate is passionate about biostatistics and the opportunity to have a significant impact to change the entire landscape of cancer.
This role will report to the Senior Director, Biostatistics.
What you'll do: