PhD in Biostatistics or related scientific discipline.
10+ years of experience in biostatistics within the biopharmaceutical industry.
3+ years designing and implementing innovative trial designs.
Experience with Phase 1-4 clinical trials and integrated analyses for regulatory submissions.
Hands-on experience with CDISC standards.
Proficient in statistical programming software (e.g., SAS, R).
Strong analytical skills and knowledge of clinical trial design and regulatory guidelines.
Responsibilities
Lead statistical activities for clinical studies, including innovative study design and agency interactions.
Coordinate with biometrics teams and external vendors to ensure quality and timeliness of deliverables.
Provide statistical input into data monitoring plans and reviews.
Review and contribute to final study reports and publications.
Identify opportunities to improve business processes for efficiency and quality.
Stay updated on emerging statistical methodologies and apply them to study design.
Mentor junior biostatisticians and external consultants.
Benefits
Highly competitive benefits package including health, dental, and vision insurance.
Fully funded HSA for high-deductible PPO Plan.
401k with 100% match on first 4% deferred, vested immediately.
Paid insurance coverage including life and disability insurance.
Flexible Spending Accounts for medical and dependent care expenses.
4 weeks Paid Time Off annually.
11 company paid holidays and Year-End shutdown.
Full Job Description
Job Type
Full-time
Description
The Role:
Responsible for leading biostatistics activities for one or more of Cardurion's clinical studies. This role will coordinate closely with statistical programming, pharmacometrics, and data management colleagues on the assigned program, and work collaboratively with cross-functional teams and external partners - providing statistical leadership to ensure that all Biometrics deliverables are accurate, timely, consistent, and executed with the highest quality standard for regulatory success.
Here's What You'll Do:
Lead statistical activities for target product profiles, innovative study design, modelling and simulation, sample size calculation, drafting of synopses, protocols, case report forms, statistical analysis plans, briefing books for agency submission, and written and direct agency interactions.
Coordinate closely with the broader biometrics team (statistical programming, pharmacometrics, and data management) and external biometrics vendors to ensure the quality and timeliness of deliverables and alignment with program objectives.
Provide statistical input into data monitoring plans and data reviews for the assigned studies.
Review and contribute to final study reports and publications to ensure appropriate use of statistical and data management procedures and interpretation.
Identify opportunities to improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output. Evaluate biometrics tools to efficiently and effectively meet program needs.
Stay current on emerging statistical methodologies and regulatory guidance (e.g., ICH E9/E9(R1)) and apply relevant developments to study design and analysis strategy.
Provide technical guidance and mentorship to junior biostatisticians and external consultants.
Here's What We'll Bring to the Table:
Highly competitive benefits package including: Blue Cross Blue Shield PPO, Delta Dental, and VSP vision
Fully funded HSA for high-deductible PPO Plan
401k (traditional and Roth offered) with 100% match on first 4% deferred. Match is vested immediately
A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability
Flexible Spending Accounts for medical and dependent care expenses
4 weeks Paid Time Off annually
11 company paid holidays and Year-End shut down
Pay Range: $245,00 - $255,000
Requirements
Here's What You'll Bring to the Table:
Education: PhD in Biostatistics or related scientific discipline.
At least 10 years of experience in biostatistics or related area within the biopharmaceutical industry, including at least 3 years of experience designing and implementing innovative trial designs.
Experience in conducting Phase 1-4 clinical trials and integrated analyses for NDA/BLA/MAA.
Thorough understanding of, and hands-on experience implementing CDISC standards.
Proficiency in statistical programming software (e.g., SAS, R) to support analysis, review, and validation of statistical deliverables.
Strong analytical and problem-solving skills, with expert knowledge of clinical trial design, statistical methodologies, and regulatory guidelines.
Strong professional presence, focus and drive to succeed, confidence, passion, and high energy.
Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively.
