Senior Manager Biostatistics
Senior Manager Biostatistics
Posted on :
31-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
31-01-2025
Job Description
Job Title: Senior Manager Biostatistics
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Job Overview
We are currently seeking a dynamic highly motivated and experienced individual for the position of Senior Manager Biostatistics. This role will support clinical development programs by providing strategic and technical leadership in the design analysis and reporting of clinical studies. The Senior Manager will collaborate with crossfunctional teams to ensure statistical integrity regulatory compliance and innovative datadriven decisionmaking throughout the drug development lifecycle. This role will be working as a biostats liaison between Sumitomo Pharma (SMP) and Sumitomo Pharma America Inc. (SMPA) teams for certain projects.
Job Duties And Responsibilities
Technical Skills
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities duties and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed
Confidential Data: All information (written verbal electronic etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital domestic partnership or civil union status; sex gender gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law please visit the following pages:
Equal Employment Opportunity is THE LAW
EEO is the Law Poster Supplement
Pay Transparency
We are currently seeking a dynamic highly motivated and experienced individual for the position of Senior Manager Biostatistics. This role will support clinical development programs by providing strategic and technical leadership in the design analysis and reporting of clinical studies. The Senior Manager will collaborate with crossfunctional teams to ensure statistical integrity regulatory compliance and innovative datadriven decisionmaking throughout the drug development lifecycle. This role will be working as a biostats liaison between Sumitomo Pharma (SMP) and Sumitomo Pharma America Inc. (SMPA) teams for certain projects.
Job Duties And Responsibilities
- List specific task and duties expected of the employee.
- Include any relevant projects or initiatives the employee will be involved in
- Highlight any key responsibilities that differentiate this role from others.
- Lead statistical activities for assigned clinical studies including protocol development statistical analysis plan (SAP) creation and final study reporting.
- Collaborate with crossfunctional teams including clinical regulatory and medical affairs to ensure study designs meet scientific and regulatory standards.
- Provide statistical expertise in study design endpoint selection sample size determination and innovative methodologies (e.g. adaptive designs Bayesian methods).
- Oversee and validate programming and statistical analyses conducted by internal or external teams.
- Interpret and communicate statistical findings to nonstatistical audiences including senior leadership regulatory agencies and external stakeholders.
- Prepare and present study results for regulatory submissions publications and internal decisionmaking.
- Work closely with SMPA teams and collaborate with counterparts at Sumitomo Pharma (SMP) in Japan on global projects ensuring alignment on statistical methodologies regulatory strategies and data analyses.
- Participate in joint meetings and initiatives to harmonize processes and share best practices across regions.
- Ensure statistical deliverables comply with regulatory guidelines (FDA EMA ICH etc.) and company SOPs.
- Contribute to the preparation of regulatory submissions including briefing documents responses to agency queries and integrated summaries of safety and efficacy (ISS/ISE).
- Mentor and guide junior biostatisticians and statistical programmers.
- Work closely with data management clinical operations clinical research and external vendors to align statistical requirements with operational deliverables.
- Stay current on advancements in biostatistics regulatory requirements and industry trends to bring innovative solutions to SMPA.
- Identify the key competencies or attributes required to excel in the role.
- Examples may include problemsolving teamwork communication etc.
- Highlight any specific qualities or traits that are important for success in the role.
- These could include attention to detail adaptability creativity etc.
Technical Skills
- Proficiency in statistical programming languages such as SAS and R.
- Strong understanding of statistical methodologies and clinical trial design.
- Knowledge of CDISC standards (SDTM ADaM) and data visualization tools.
- Excellent verbal and written communication skills.
- Strong problemsolving and criticalthinking abilities.
- Effective leadership and collaboration skills in a crossfunctional team environment.
- Master’s degree in Statistics Biostatistics or a related field (Ph.D. preferred).
- 4 years of biostatistics experience in the pharmaceutical biotechnology or CRO industry.
- Proven track record of leading statistical activities for clinical trials in various phases (IIV).
- Experience with regulatory submissions (e.g. INDs NDAs BLAs) and interacting with health authorities.
- Familiarity with therapeutic areas such as oncology CNS urology or women’s health is a plus.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities duties and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time as needed
Confidential Data: All information (written verbal electronic etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital domestic partnership or civil union status; sex gender gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law please visit the following pages:
Equal Employment Opportunity is THE LAW
EEO is the Law Poster Supplement
Pay Transparency
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Employment Type
Full Time
Key Skills
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