Senior Director, Biostatistics
Remote
Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing atscale.
Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.
Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.
Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!
The Senior Director, Biostatistics provides strategic and organizational leadership for the biostatistics function, driving statistical excellence across the portfolio of clinical development programs. This role is responsible for shaping development and evidence generating strategies, influencing key regulatory and business decisions, and ensuring the delivery of high-quality statistical support. The Senior Director partners closely with executive leadership and cross-functional stakeholders to advance company objectives and optimize portfolio outcomes.
Responsibilities
- Provide strategic leadership for biostatistics across multiple development programs, therapeutic areas, or product portfolios from early development through registration and post-marketing activities
- Establish and drive the statistical strategy for clinical development programs, ensuring alignment with regulatory, scientific, and business objectives
- Serve as the senior biostatistics representative on cross-functional governance, portfolio review, and development strategy committees
- Oversee statistical contributions to major regulatory interactions, including meetings with global health authorities and submissions supporting product approvals
- Influence clinical development strategy through innovative trial designs, endpoint selection, estimand strategies, and evidence-generation approaches
- Partner closely with Clinical Development, Regulatory Affairs, Data Sciences, Medical Affairs, and Commercial teams to support asset and portfolio decision-making
- Drive statistical excellence and ensure the application of industry best practices, emerging methodologies, and regulatory guidance across the organization
- Provide strategic oversight of statistical analysis plans, study designs, integrated analyses, and submission-ready deliverables for pivotal development programs
- Build and maintain strong relationships with external stakeholders, including key opinion leaders, regulatory agencies, academic collaborators, and industry consortia
- Identify organizational risks and opportunities, proactively recommending solutions that enhance development success and operational effectiveness
- Influences enterprise-level decisions regarding portfolio prioritization, development strategy, and resource allocation
- Recognized as a trusted advisor to executive leadership on statistical, regulatory, and scientific matters
Qualifications and Skills
- A PhD degree in Statistics or Biostatistics with at least 15 years' working experience in pharmaceutical or biotechnology companies
- Solid statistical knowledge and experience in clinical trial design from early to late phase, data analysis and reporting
- Strong track record using statistical methods to solve real problems emerged in clinical trials and resulted in right decision-making and/or compound advancement
- Rich experience is authoring study SAP and TFL shells and driving the review process to achieve consensus among review functions to deliver the final versions of high quality
- Extensive experience in managing statistical vendors to implement SAP and deliver study results with quality and speed
- Solid knowledge and extensive experience of using statistical computational languages, such as SAS, to perform data analysis
- Working knowledge of regulatory guidance relevant to clinical trials from design to analysis
- Demonstrated capacity of collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Data Science and other relevant functions to deliver common goals
- Strong organizational and project management skills; demonstrated interests of continued learning and growing
- Detail-oriented and hold high standards of excellence for own work products
- Deliver and communicate effectively in the work-from-home environment
- Excellent interpersonal skills and is a good team player
The starting base pay range for this position is $259,522.00 - $296,557.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.
Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
Senior Director, Biostatistics
Remote
Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing atscale.
Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.
Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.
Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!
The Senior Director, Biostatistics provides strategic and organizational leadership for the biostatistics function, driving statistical excellence across the portfolio of clinical development programs. This role is responsible for shaping development and evidence generating strategies, influencing key regulatory and business decisions, and ensuring the delivery of high-quality statistical support. The Senior Director partners closely with executive leadership and cross-functional stakeholders to advance company objectives and optimize portfolio outcomes.
Responsibilities
- Provide strategic leadership for biostatistics across multiple development programs, therapeutic areas, or product portfolios from early development through registration and post-marketing activities
- Establish and drive the statistical strategy for clinical development programs, ensuring alignment with regulatory, scientific, and business objectives
- Serve as the senior biostatistics representative on cross-functional governance, portfolio review, and development strategy committees
- Oversee statistical contributions to major regulatory interactions, including meetings with global health authorities and submissions supporting product approvals
- Influence clinical development strategy through innovative trial designs, endpoint selection, estimand strategies, and evidence-generation approaches
- Partner closely with Clinical Development, Regulatory Affairs, Data Sciences, Medical Affairs, and Commercial teams to support asset and portfolio decision-making
- Drive statistical excellence and ensure the application of industry best practices, emerging methodologies, and regulatory guidance across the organization
- Provide strategic oversight of statistical analysis plans, study designs, integrated analyses, and submission-ready deliverables for pivotal development programs
- Build and maintain strong relationships with external stakeholders, including key opinion leaders, regulatory agencies, academic collaborators, and industry consortia
- Identify organizational risks and opportunities, proactively recommending solutions that enhance development success and operational effectiveness
- Influences enterprise-level decisions regarding portfolio prioritization, development strategy, and resource allocation
- Recognized as a trusted advisor to executive leadership on statistical, regulatory, and scientific matters
Qualifications and Skills
- A PhD degree in Statistics or Biostatistics with at least 15 years' working experience in pharmaceutical or biotechnology companies
- Solid statistical knowledge and experience in clinical trial design from early to late phase, data analysis and reporting
- Strong track record using statistical methods to solve real problems emerged in clinical trials and resulted in right decision-making and/or compound advancement
- Rich experience is authoring study SAP and TFL shells and driving the review process to achieve consensus among review functions to deliver the final versions of high quality
- Extensive experience in managing statistical vendors to implement SAP and deliver study results with quality and speed
- Solid knowledge and extensive experience of using statistical computational languages, such as SAS, to perform data analysis
- Working knowledge of regulatory guidance relevant to clinical trials from design to analysis
- Demonstrated capacity of collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Data Science and other relevant functions to deliver common goals
- Strong organizational and project management skills; demonstrated interests of continued learning and growing
- Detail-oriented and hold high standards of excellence for own work products
- Deliver and communicate effectively in the work-from-home environment
- Excellent interpersonal skills and is a good team player
The starting base pay range for this position is $259,522.00 - $296,557.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.
Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and vesting after the turn of the first month after your start date
- Flexible time off
- Generous parental leave and some fun fringe perks!
