Senior Director, Biostatistics
Research – Biostatistics /
OM1 is on a mission to improve health outcomes by unlocking the power of data. We are a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. Our interdisciplinary team uses expertise in medicine, software, Big Data, machine learning, public health and mathematics to transform records from a diverse set of sources into enriched, research grade data which allows us to generate unique insights in a variety of disease areas.
As Senior Director of Biostatistics, you will be responsible for the development and oversight of biostatistics and statistical programming strategies, and personnel to ensure the efficient and accurate analysis of real-world data. You will lead, develop and implement statistical solutions to assure timely completions of biostatistics deliverables. You will develop and implement biostatistics practices and operating procedures in compliance with industry standards ensuring high standards of data integrity and quality to optimize compliance, effectiveness and efficiency. Assist with developing organizational policies and oversee their implementation. Interact internally and externally with executive-level management.
What You'll Do
- Serve as Senior Director of Biostatistics and lead the team in conducting real-world data analyses, including clinical effectiveness, comparative effectiveness, healthcare resource utilization and patient-reported outcome studies
- Lead the effective development and implementation of Biostatistics strategies consistent with the company’s strategic objectives, and ensure the overall effective operations of the biostatistics and statistical programming team
- Provides guidance to employee's development plans and carries out performance reviews and feedback.
- Ensure the high quality and timeliness of deliverables from Biostatistics.
- Oversee and ensure the high-quality level of the Biostatistics expert review process.
- Drives strategy for processes improvement, contributes to new departmental SOPs, and provides training on statistical topics and departmental SOPs.
- Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner.
What Experience You'll Bring
- PhD (strongly preferred) or MS in Biostatistics or Statistics or equivalent.
- Typically requires 12 years of experience with a PhD or 15 years of experience with a master's degree, or the equivalent combination of education and experience.
- At least 10 years experience in pharmaceutical/biotech/CRO industry settings required, including work with real world data (i.e. electronic health record and claims) and solid understanding of real world health care data elements and common data structures.
- Strong knowledge of theoretical and applied statistics. Experience developing statistical strategies for regulatory-grade RWD studies preferred.
- Prior people management experience required
- Previous project/process leadership experience required.
- Expertise in advanced/complex statistical methods for observational data is required
- Experience programming in SAS required. Experience with other relevant statistical programming languages (e.g., R, Python) preferred.
- Able to understand the business implications of decisions and impact on the customer.
- Demonstrated success leading statistical strategy, analysis, and design of real-world studies across therapeutic areas.
- Experience developing and implementing department standards and lead process improvements.
- Excellent collaboration, organizational/ leadership abilities, and interpersonal skills.
If you’re excited about this role but your past experience doesn’t align perfectly with every qualification, we encourage you to apply anyway. You may be just the right candidate for this or other roles.
OM1 is an equal employment opportunity employer and considers qualified applicants without regard to gender, sexual orientation, gender identity, religion, race, veteran or disability status. At OM1 ensuring that people feel respected, valued, and included is essential to our success. We are committed to working together to provide a work environment that embraces the principles of diversity, equity, and inclusion.