Sr Manager Biostatistics
We have a current opportunity for a Sr Manager Biostatistics on a permanent basis. This position can be fully remote with occasional travel. For further information about this position please apply. Job Title: Senior Manager, Biostatistics Job Type: Full-Time Job Summary: We are seeking an experienced and highly motivated Senior Manager of Biostatistics to join our dynamic team. The successful candidate will lead a team of biostatisticians and provide strategic direction for biostatistical activities across multiple projects. This role requires 5 years minimum of managerial experience, excellent communication skills, and a deep understanding of biostatistics in the context of clinical trials and regulatory submissions. Key Responsibilities: Lead and manage a team of biostatisticians, providing mentorship, guidance, and performance evaluations. Develop and implement biostatistical strategies for clinical trials, ensuring compliance with regulatory requirements. Collaborate with cross-functional teams, including clinical development, data management, and regulatory affairs, to ensure the successful design, execution, and reporting of clinical studies. Oversee the development of statistical analysis plans, study protocols, and clinical study reports. Ensure the accuracy and integrity of biostatistical analyses and data interpretation. Represent the biostatistics function in meetings with regulatory agencies and other external stakeholders. Stay current with industry trends, regulatory guidelines, and best practices in biostatistics and clinical research. Contribute to the development and implementation of departmental policies and procedures. Qualifications: Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. Minimum of 10 years of experience in biostatistics, with at least 5 years in a managerial role. Proven experience in the design and analysis of clinical trials. Hands on experience in data science applied to clinical study data, including real world data (RWD). Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, 510k). Proficiency in statistical software (e.g., SAS, R). Excellent leadership, communication, and interpersonal skills. Ability to work effectively in a fast-paced, collaborative environment. Strong problem-solving and decision-making abilities. Preferred Qualifications: Experience in working within medical device industry Experience with regulatory submissions and interactions with regulatory agencies (FDA, 510k) Knowledge of data management and clinical data standards (e.g., CDISC). Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. Retirement savings plan with company match. Professional development opportunities. Flexible work arrangements.
US$160000 - US$200000 per year
New Jersey
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AD Biostatistics
We have a current opportunity for a AD Biostatistics on a permanent basis. The position will be based in New Jersey (3x a week). For further information about this position please apply. Job Title: Associate Director of Biostatistics Location: New Jersey, USA | 3x a week on site Company Overview: We are a dynamic and innovative biotech company focused on developing cutting-edge therapies in the fields of oncology and central nervous system (CNS) disorders. Our mission is to bring life-changing treatments to patients through rigorous scientific research and clinical excellence. Position Summary: The Associate Director of Biostatistics will play a pivotal role in our clinical development programs, providing statistical leadership and expertise in the design, analysis, and interpretation of clinical trials. This position will collaborate closely with cross-functional teams to ensure the integrity and accuracy of our clinical data, ultimately supporting the advancement of our oncology and CNS pipelines. Key Responsibilities: Lead the statistical design, analysis, and reporting of clinical trials in oncology and CNS. Develop and review statistical analysis plans (SAPs) and ensure compliance with regulatory requirements. Provide statistical input into clinical development plans, study protocols, and regulatory submissions. Collaborate with clinical, regulatory, and data management teams to ensure high-quality data collection and analysis. Oversee the work of biostatisticians and statistical programmers, providing mentorship and guidance. Conduct exploratory data analyses and support the development of publications and presentations. Stay current with industry trends and advancements in biostatistics and clinical trial methodologies. Qualifications: Ph.D. or M.S. in Biostatistics, Statistics, or a related field. Minimum of 5 years of experience in biostatistics within the biotech or pharmaceutical industry, with a focus on oncology and/or CNS. Proven track record of leading statistical aspects of clinical trials from design to regulatory submission. Strong knowledge of statistical software (e.g., SAS, R) and clinical trial databases. Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment. Detail-oriented with strong problem-solving skills and the ability to manage multiple projects simultaneously. Why Join Us: Be part of a passionate team dedicated to making a difference in patients' lives. Opportunity to work on innovative therapies in oncology and CNS. Competitive salary and benefits package. Collaborative and supportive work environment
US$150000 - US$180000 per year
New Jersey
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Snr D/ ED Biostatistics
We have a current opportunity for a Snr D/ ED Biostatistics on a permanent basis. The position will be based in Pennsylvania. For further information about this position please apply. Job Title: Snr/Executive Director, Biostatistics Report: Chief Data and Analytics Officer Location: Pennsylvania, USA Job Type: Full-Time Overview: The Executive Director of Biostatistics will be an individual contributor that will lead multiple biostatistical activities, covering all phases of clinical development. This position will be a hands on role with a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents. Key Responsibilities: Lead and manage the biostatistics team, fostering a collaborative and high-performing environment. Provide statistical expertise and strategic input for clinical development plans, study designs, and regulatory submissions. Ensure the quality and integrity of statistical deliverables, including protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs). Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to support the company's therapeutic portfolio. Represent the company in external scientific and regulatory forums, demonstrating leadership and influencing industry standards. Drive continuous improvement initiatives within the biostatistics function to enhance efficiency and innovation. Qualifications: PhD in Biostatistics, Statistics, or a related field. Minimum of 10+ years of relevant industry experience, with at least 3 years in a leadership role managing a global team Experience in Liver Diseases is preferred, but open to all TAs Strong expertise in statistical methodologies and their application in clinical trials. Experience with regulatory submissions and a thorough understanding of worldwide regulatory requirements. Excellent communication skills, both written and verbal, with the ability to explain complex statistical concepts to non-statisticians. Proven track record of leading high-performing teams and driving innovation in biostatistics.
US$260000 - US$320000 per year
Conshohocken
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Snr D/ ED Biostatistics
We have a current opportunity for a Snr D/ ED Biostatistics on a permanent basis. The position will be based in Pennsylvania. For further information about this position please apply. Job Title: Snr/Executive Director, Biostatistics Report: Chief Data and Analytics Officer Location: Pennsylvania, USA Job Type: Full-Time Overview: The Executive Director of Biostatistics will be an individual contributor that will lead multiple biostatistical activities, covering all phases of clinical development. This position will be a hands on role with a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents. Key Responsibilities: Lead and manage the biostatistics team, fostering a collaborative and high-performing environment. Provide statistical expertise and strategic input for clinical development plans, study designs, and regulatory submissions. Ensure the quality and integrity of statistical deliverables, including protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs). Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to support the company's therapeutic portfolio. Represent the company in external scientific and regulatory forums, demonstrating leadership and influencing industry standards. Drive continuous improvement initiatives within the biostatistics function to enhance efficiency and innovation. Qualifications: PhD in Biostatistics, Statistics, or a related field. Minimum of 10+ years of relevant industry experience, with at least 3 years in a leadership role managing a global team Experience in Liver Diseases is preferred, but open to all TAs Strong expertise in statistical methodologies and their application in clinical trials. Experience with regulatory submissions and a thorough understanding of worldwide regulatory requirements. Excellent communication skills, both written and verbal, with the ability to explain complex statistical concepts to non-statisticians. Proven track record of leading high-performing teams and driving innovation in biostatistics.
US$260000 - US$320000 per year
Conshohocken
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Snr D/ ED Biostatistics
We have a current opportunity for a Snr D/ ED Biostatistics on a permanent basis. The position will be based in Pennsylvania. For further information about this position please apply. Job Title: Snr/Executive Director, Biostatistics Report: Chief Data and Analytics Officer Location: Pennsylvania, USA Job Type: Full-Time Overview: The Executive Director of Biostatistics will be an individual contributor that will lead multiple biostatistical activities, covering all phases of clinical development. This position will be a hands on role with a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents. Key Responsibilities: Lead and manage the biostatistics team, fostering a collaborative and high-performing environment. Provide statistical expertise and strategic input for clinical development plans, study designs, and regulatory submissions. Ensure the quality and integrity of statistical deliverables, including protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs). Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to support the company's therapeutic portfolio. Represent the company in external scientific and regulatory forums, demonstrating leadership and influencing industry standards. Drive continuous improvement initiatives within the biostatistics function to enhance efficiency and innovation. Qualifications: PhD in Biostatistics, Statistics, or a related field. Minimum of 10+ years of relevant industry experience, with at least 3 years in a leadership role managing a global team Experience in Liver Diseases is preferred, but open to all TAs Strong expertise in statistical methodologies and their application in clinical trials. Experience with regulatory submissions and a thorough understanding of worldwide regulatory requirements. Excellent communication skills, both written and verbal, with the ability to explain complex statistical concepts to non-statisticians. Proven track record of leading high-performing teams and driving innovation in biostatistics.
US$260000 - US$320000 per year
Conshohocken
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Snr D/ ED Biostatistics
We have a current opportunity for a Snr D/ ED Biostatistics on a permanent basis. The position will be based in Pennsylvania. For further information about this position please apply. Job Title: Snr/Executive Director, Biostatistics Report: Chief Data and Analytics Officer Location: Pennsylvania, USA Job Type: Full-Time Overview: The Executive Director of Biostatistics will be an individual contributor that will lead multiple biostatistical activities, covering all phases of clinical development. This position will be a hands on role with a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents. Key Responsibilities: Lead and manage the biostatistics team, fostering a collaborative and high-performing environment. Provide statistical expertise and strategic input for clinical development plans, study designs, and regulatory submissions. Ensure the quality and integrity of statistical deliverables, including protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs). Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to support the company's therapeutic portfolio. Represent the company in external scientific and regulatory forums, demonstrating leadership and influencing industry standards. Drive continuous improvement initiatives within the biostatistics function to enhance efficiency and innovation. Qualifications: PhD in Biostatistics, Statistics, or a related field. Minimum of 10+ years of relevant industry experience, with at least 3 years in a leadership role managing a global team Experience in Liver Diseases is preferred, but open to all TAs Strong expertise in statistical methodologies and their application in clinical trials. Experience with regulatory submissions and a thorough understanding of worldwide regulatory requirements. Excellent communication skills, both written and verbal, with the ability to explain complex statistical concepts to non-statisticians. Proven track record of leading high-performing teams and driving innovation in biostatistics.
US$260000 - US$320000 per year
Conshohocken
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AD Biostatistics
We have a current opportunity for a AD Biostatistics on a permanent basis. The site location is in New Jersey. This position can be remote or hybrid on site. We're seeking talented Biostatisticians that have pharma industry experience in Oncology early/late phase. For further information about this position please apply. Job Title: Associate Director, Biostatistics Location: New Jersey Company Overview: We are a mid-sized oncology pharmaceutical company dedicated to developing innovative cancer therapies. Our mission is to improve patient outcomes and quality of life through cutting-edge research and development. Position Overview: The Associate Director of Biostatistics will provide strategic and statistical leadership for our late stage oncology clinical development programs. This role involves designing and analyzing clinical trials, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to support the development of new cancer treatments. Key Responsibilities: Provide statistical leadership and support for oncology clinical trials, including study design, statistical analysis plans, and data interpretation. Collaborate with clinical teams to develop case report forms and ensure accurate data collection. Conduct statistical analyses and provide input for clinical study reports, scientific presentations, and manuscripts. Lead discussions with regulatory authorities and serve as a statistical responder in FDA advisory committee meetings. Develop and implement statistical standard operating procedures (SOPs) and contribute to process improvements. Mentor and develop junior biostatisticians and other team members. Stay current with advancements in biostatistics and oncology research to ensure the application of best practices. Qualifications: Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. Minimum of 8 years of experience in biostatistics, with at least 5 years in the pharmaceutical or biotechnology industry. Strong knowledge of statistical methods and their application in clinical trials. Experience with regulatory submissions and interactions with health authorities. Proficiency in statistical software (e.g., SAS, R). Excellent communication and leadership skills. Ability to work collaboratively in a cross-functional team environment. Preferred Qualifications: Experience in oncology clinical trials. Familiarity with FDA and EMA guidelines for drug development. Demonstrated ability to lead and manage multiple projects simultaneously. Benefits: Competitive salary and performance-based bonuses. Comprehensive health, dental, and vision insurance. 401(k) with company match. Professional development opportunities. Flexible work arrangements.
US$180000 - US$210000 per year
New Jersey
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Associate Director / Director, Biostatistics
We have a current opportunity for an Associate Director / Director, Biostatistics with a leading pharmaceutical company. This Biostatistics Leader will join their team at the highest level, taking on a critical role in driving the statistics efforts across all phases of clinical development. Job Title: Associate Director / Director, Biostatistics Key Responsibilities: Lead and manage the biostatistics team, fostering a collaborative and high-performing environment. Provide statistical expertise and strategic input for clinical development plans, study designs, and regulatory submissions. Ensure the quality and integrity of statistical deliverables, including protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs). Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to support the company's therapeutic portfolio. Drive continuous improvement initiatives within the biostatistics function to enhance efficiency and innovation. Qualifications: PhD in Biostatistics, Statistics, or a related field (Mathematics). Minimum of 4+ years of relevant industry experience Open to all TAs Strong expertise in statistical methodologies and their application in clinical trials. Experience with regulatory submissions / filings
US$180000 - US$240000 per year
New York
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Snr D/ ED Biostatistics
We have a current opportunity for a Snr D/ ED Biostatistics on a permanent basis. The position will be based in Pennsylvania. For further information about this position please apply. Job Title: Snr/Executive Director, Biostatistics Report: Chief Data and Analytics Officer Location: Pennsylvania, USA Job Type: Full-Time Overview: The Executive Director of Biostatistics will be an individual contributor that will lead multiple biostatistical activities, covering all phases of clinical development. This position will be a hands on role with a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents. Key Responsibilities: Lead and manage the biostatistics team, fostering a collaborative and high-performing environment. Provide statistical expertise and strategic input for clinical development plans, study designs, and regulatory submissions. Ensure the quality and integrity of statistical deliverables, including protocols, statistical analysis plans (SAPs), and clinical study reports (CSRs). Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to support the company's therapeutic portfolio. Represent the company in external scientific and regulatory forums, demonstrating leadership and influencing industry standards. Drive continuous improvement initiatives within the biostatistics function to enhance efficiency and innovation. Qualifications: PhD in Biostatistics, Statistics, or a related field. Minimum of 10+ years of relevant industry experience, with at least 3 years in a leadership role managing a global team Experience in Liver Diseases is preferred, but open to all TAs Strong expertise in statistical methodologies and their application in clinical trials. Experience with regulatory submissions and a thorough understanding of worldwide regulatory requirements. Excellent communication skills, both written and verbal, with the ability to explain complex statistical concepts to non-statisticians. Proven track record of leading high-performing teams and driving innovation in biostatistics.
US$260000 - US$320000 per year
Conshohocken
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Manager Clinical Data Management
We have a current opportunity for a Manager CDM on a permanent basis. The position will be based in Cambridge, Massachusetts. For further information about this position please apply. Job Title: Manager, Clinical Data Management Location: Massachusetts, USA | onsite position Job Type: Full-time Job Summary: We are seeking an experienced and detail-oriented Manager of Clinical Data Management to join our team. The successful candidate will oversee the data management activities for clinical trials, ensuring the integrity, accuracy, and security of clinical data. This role requires strong leadership skills, a deep understanding of clinical data management processes, and the ability to work collaboratively with cross-functional teams. Key Responsibilities: Design and Implement Data Collection Systems: Develop and maintain efficient systems and tools for clinical data collection, ensuring compliance with regulatory standards. Data Management Oversight: Supervise the data management process, including data collection, entry, verification, and cleaning to ensure high-quality data. Regulatory Compliance: Ensure all data management activities comply with Good Clinical Practice (GCP) and other relevant regulatory guidelines. Collaboration: Work closely with investigators, biostatisticians, and other healthcare professionals to gather, interpret, and analyze clinical data. Documentation: Prepare and maintain comprehensive documentation, including data management plans, standard operating procedures (SOPs), and clinical study reports. Team Leadership: Train, mentor, and supervise data management staff, fostering a collaborative and productive work environment. Problem-Solving: Address and resolve data queries and discrepancies, ensuring data consistency and accuracy. Project Management: Manage timelines and deliverables for data management activities, ensuring project deadlines are met. Qualifications: Education: Bachelor's degree in Life Sciences, Computer Science, or a related field. Advanced degree preferred. Experience: Minimum of 10 years of experience in clinical data management, with at least 2 years in a supervisory or managerial role within a CRO or pharmaceutical environment. Technical Skills: Proficiency in clinical data management systems (e.g., EDC systems), database management, and statistical software. Regulatory Knowledge: In-depth knowledge of GCP, FDA, and other regulatory requirements. Soft Skills: Excellent communication, leadership, and problem-solving skills. Ability to work effectively in a team-oriented environment.
US$140000 - US$160000 per year
Massachusetts
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Director / Senior Director, Statistical Programming
Title: Director / Senior Director, Statistical Programming Location: Greater Philadelphia Area Job Summary: The Director/ Senior Director of Statistical Programming will lead and oversee all statistical programming functions, ensuring the delivery of high-quality support for clinical trials and regulatory submissions. This role involves strategic planning, resource management, and collaboration with cross-functional teams to achieve team and company-wide goals. Key Responsibilities: Oversee the planning, execution, and delivery of statistical programming projects, ensuring timelines and quality standards are met. Develop and implement programming standards, guidelines, and best practices. Ensure compliance with regulatory requirements and industry standards. Work closely with biostatisticians, data managers, and other stakeholders to ensure seamless integration of statistical programming activities within clinical trials. Lead the preparation and review of programming deliverable for regulatory submissions, ensuring accuracy and completeness. Qualifications: Masters in Statistics, Biostatistics, Computer Science, or a related field. Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotechnology industry Proficiency in SAS, R, and other statistical programming languages. Strong understanding of CDISC standards (SDTM, ADaM). Demonstrated experience in leading a clinical asset through all phases of development Proven expertise in regulatory submissions, including leading and managing submission processes Report onsite 3 days a week
US$200000 - US$260000 per year
Philadelphia
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AD Biostatistics
We have a current opportunity for a AD Biostatistics on a permanent basis. The position will be based in fort lee. For EPM Scientific is representing a global, science-driven oncology company dedicated to discovering and developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With one of the largest oncology/hematology research teams in the world, they are committed to addressing a broad range of cancers through our extensive pipeline of cutting-edge therapies. The successful candidate will play a pivotal role in providing statistical leadership and support for clinical development programs. This position requires a deep understanding of biostatistics, strong analytical skills, and the ability to work collaboratively with cross-functional teams. Key Responsibilities: Provide statistical leadership and guidance for clinical development programs. Develop and implement statistical analysis plans for clinical trials. Collaborate with clinical, regulatory, and data management teams to ensure the integrity and accuracy of clinical data. Perform statistical analyses and interpret results to support clinical trial reports and regulatory submissions. Ensure compliance with regulatory requirements and industry standards. Mentor and provide guidance to junior biostatisticians. Stay current with advancements in biostatistics and clinical trial methodologies. Qualifications: Ph.D. or Master's degree in Biostatistics, Statistics, or a related field. Minimum of 8 years of experience in biostatistics within the pharmaceutical or biotechnology industry. Proven track record of successful regulatory submissions. Strong knowledge of statistical software (e.g., SAS, R). Excellent communication and interpersonal skills. Ability to work effectively in a team-oriented environment. Strong problem-solving and analytical skills.
US$185000 - US$200000 per year
Fort Lee
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