EPM Scientific
Senior Director Biostatistics Oncology (People Manager)
EPM Scientific, Boston, Massachusetts, us, 02298
We have a current opportunity for a Senior Director Biostatistics Oncology (People Manager) on a permanent basis. The position will be based in Boston, MA. For further information about this position please apply.
Ensure all your application information is up to date and in order before applying for this opportunity.
Job Title: Senior Director, Biostatistics - Oncology (People Manager)
Location: Boston, MA or remote
Department: Biostatistics / Clinical Development
Reports To: Vice President, Biostatistics
Position Summary:
We are seeking a strategic and experienced
Senior Director of Biostatistics
to lead and grow our oncology biostatistics team. This leadership role is pivotal in shaping statistical strategy across our oncology portfolio, ensuring scientific rigor, regulatory compliance, and operational excellence. The ideal candidate will be a collaborative leader with deep expertise in oncology clinical trials and a passion for mentoring and developing high-performing teams.
Key Responsibilities:
Leadership & People Management
Lead, mentor, and develop a team of biostatisticians supporting oncology clinical trials across all phases. Foster a culture of innovation, collaboration, and continuous learning. Provide career development guidance, performance feedback, and succession planning.
Strategic Oversight
Define and drive statistical strategy for oncology programs in collaboration with cross-functional leaders. Serve as the statistical lead on key development programs, regulatory submissions, and advisory meetings. Ensure alignment of statistical deliverables with clinical and regulatory objectives.
Operational Excellence
Oversee statistical planning, analysis, and reporting for clinical trials, ensuring high quality and timely delivery. Collaborate with Clinical Development, Data Management, Programming, Regulatory Affairs, and other stakeholders. Ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH).
Innovation & Best Practices
Champion the use of innovative statistical methodologies and data science approaches in oncology. Contribute to the development and implementation of departmental SOPs, templates, and standards. Represent the company in external collaborations, conferences, and regulatory interactions.
Qualifications:
PhD degree in Biostatistics, Statistics, or related field. Minimum of 12 years of experience in biostatistics within the pharmaceutical or biotechnology industry, with at least 10 years in oncology. Proven experience managing and developing teams of statisticians. Strong knowledge of oncology clinical trial design, survival analysis, and regulatory requirements. Excellent communication, leadership, and interpersonal skills. Experience with regulatory submissions (e.g., NDA, BLA, MAA) and interactions with health authorities.
Preferred Qualifications:
Extensive Experience within oncology, precision medicine Familiarity with adaptive designs, Bayesian methods, or real-world evidence. Regulatory interraction 3 years + in a Leadership position with direct reports Active participation in professional statistical organizations or working groups.
Ensure all your application information is up to date and in order before applying for this opportunity.
Job Title: Senior Director, Biostatistics - Oncology (People Manager)
Location: Boston, MA or remote
Department: Biostatistics / Clinical Development
Reports To: Vice President, Biostatistics
Position Summary:
We are seeking a strategic and experienced
Senior Director of Biostatistics
to lead and grow our oncology biostatistics team. This leadership role is pivotal in shaping statistical strategy across our oncology portfolio, ensuring scientific rigor, regulatory compliance, and operational excellence. The ideal candidate will be a collaborative leader with deep expertise in oncology clinical trials and a passion for mentoring and developing high-performing teams.
Key Responsibilities:
Leadership & People Management
Lead, mentor, and develop a team of biostatisticians supporting oncology clinical trials across all phases. Foster a culture of innovation, collaboration, and continuous learning. Provide career development guidance, performance feedback, and succession planning.
Strategic Oversight
Define and drive statistical strategy for oncology programs in collaboration with cross-functional leaders. Serve as the statistical lead on key development programs, regulatory submissions, and advisory meetings. Ensure alignment of statistical deliverables with clinical and regulatory objectives.
Operational Excellence
Oversee statistical planning, analysis, and reporting for clinical trials, ensuring high quality and timely delivery. Collaborate with Clinical Development, Data Management, Programming, Regulatory Affairs, and other stakeholders. Ensure compliance with global regulatory requirements (e.g., FDA, EMA, ICH).
Innovation & Best Practices
Champion the use of innovative statistical methodologies and data science approaches in oncology. Contribute to the development and implementation of departmental SOPs, templates, and standards. Represent the company in external collaborations, conferences, and regulatory interactions.
Qualifications:
PhD degree in Biostatistics, Statistics, or related field. Minimum of 12 years of experience in biostatistics within the pharmaceutical or biotechnology industry, with at least 10 years in oncology. Proven experience managing and developing teams of statisticians. Strong knowledge of oncology clinical trial design, survival analysis, and regulatory requirements. Excellent communication, leadership, and interpersonal skills. Experience with regulatory submissions (e.g., NDA, BLA, MAA) and interactions with health authorities.
Preferred Qualifications:
Extensive Experience within oncology, precision medicine Familiarity with adaptive designs, Bayesian methods, or real-world evidence. Regulatory interraction 3 years + in a Leadership position with direct reports Active participation in professional statistical organizations or working groups.