- Provide statistically rigorous expertise including hands on development on study design, statistical analysis plans, communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.
- Accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects.
- Write Statistical Analysis Plans including mock TFLs for studies and cross study integrated analyses.
- Partner closely with Data Management on eCRF and DB design, data cleaning and activities to support in stream data cleaning, freezing/locking subjects and database lock.
- Partner closely with Statistical Programming to draft SDTM/ADaM specifications, QC datasets and tables, listings and figures.
- Support regulatory responses and interactions, CSRs, IB, DSURs, external clinical data presentations at conferences, publications, etc.
- Develop effective collaborations internally and externally including, but not limited to, data management, statistical programming, clinical teams, regulatory and industry professionals.
- Ensure study and project level statistical activities are documented and conducted in compliance with relevant regulatory requirements.
- Provide statistical input and leadership to cross-functional activities, in collaboration with study managers for assigned studies or regulatory submissions.
- Develop SOPs, guidelines, training and process flows for Statistics
- Other projects as deemed appropriate.
- Advanced degree in statistics or biostatistics; PhD preferred.
- A minimum of 6-8 years of experience in Pharma/Biotech designing phase 1-4 clinical trials, analyzing and reporting clinical trial data.
- A minimum of 6-8 years of experience in R and SAS programming including R packages, graphics (e.g. waterfall, spider, box plots, forest plots, etc) in a clinical trials setting.
- A minimum of 4 years of experience in oncology including regulatory submission experience for oncology medicines.
- Strong technical and statistical expertise including interim analyses, Bayesian approaches, mixed models, survival analysis methods, etc.; expertise in statistical software tools, e.g. EAST,
- Relevant clinical trial, real-world data, and business experience providing an understanding of the processes associated with clinical, regulatory, and marketing operations.
- Capability to provide statistical leadership to cross -functional teams at the protocol or project level.
- Demonstrated track record of collaborating on teams; Strong team-player.
- Positive, can-do, collaborative attitude; high emotional intelligence.
- Effective verbal and written communication skills.
- Ability to multi-task/ prioritize and time management of daily activities.
- Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project)
- High attention to detail and accuracy.
- Demonstrates high level of accuracy and effective oral and written communication skills.
- Flexibility within a rapidly changing environment
- Excellent ability to work in a goal and team-oriented setting.
- Well-developed organizational skills and the ability to thrive under pressure.
-
Associate Director Biostatistics
3 weeks ago
Meet New Jersey, United StatesCompany Overview: · Our client is a pioneering biopharmaceutical company dedicated to revolutionizing patient care through innovative drug discovery technologies. Leveraging cutting-edge advancements in molecular visualization, computational chemistry, and data integration, our c ...
-
Associate Director, Biostatistics
2 weeks ago
Daiichi Sankyo, Inc. New Jersey, United StatesJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...
-
Volastra Therapeutics New York, United StatesCOMPANY · Volastra Therapeutics, Inc. is a clinical stage oncology biotechnology company based in New York City. Founded by Lewis Cantley, Samuel Bakhoum and Olivier Elemento, Volastra is focused on developing therapeutics that exploit chromosomal instability (CIN) as a unique v ...
-
Associate Director of Biostatistics
2 weeks ago
Formation Bio New York, United States Full timeAbout Formation Bio · At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently. · At Formation Bio we license clinical st ...
-
Associate Director of Biostatistics
1 week ago
Formation Bio New York, United StatesAbout Formation BioAt Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.At Formation Bio we license clinical stage dr ...
-
Neurology Biostatistics Director
2 weeks ago
PSG Global Solutions New York, United StatesWe're looking for a · Neurology Biostatistics Director , working in · Pharmaceuticals · and · Medical Products · industry in · 155 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, United States . · Reviews protocols and other study documents that are developed in · colla ...
-
Associate Director Biostatistics
4 weeks ago
Daiichi Sankyo, Inc. New Jersey, United StatesJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...
-
Director, Biostatistics
1 week ago
Regeneron Pharmaceuticals, Inc. Basking Ridge, United States Full timeDirector, Biostatistics Early Clinical Development Gene Therapy The Director of Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic area. · In this role, a typical day might include:This position is for a qualified st ...
-
Director, Biostatistics
1 week ago
BioSpace Basking Ridge, United StatesJob Details · Director, Biostatistics Early Clinical Development Gene Therapy · The Director of Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic area. · In this role, a typical day might include: · This position i ...
-
Director, Biostatistics
2 weeks ago
System One Basking Ridge, United StatesJob Title: Director, Biostatistics (Oncology Indication Lead) · Full time permanent - Direct with a global pharmaceutical company · Location: Remote, US Based only, must be located in EST or CST time zones. Must be able to travel to NJ quarterly. · Prior experience as a Statisti ...
-
Director, Biostatistics
2 weeks ago
System One Basking Ridge, United StatesJob Title : Director, Biostatistics (Oncology Indication Lead) · Full time permanent - Direct with a global pharmaceutical company · Location: Remote, US Based only, must be located in EST or CST time zones. · Must be able to travel to NJ quarterly. · Prior experience as a Stat ...
-
Director, Biostatistics
3 weeks ago
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our wo ...
-
Director, Biostatistics
1 week ago
Daiichi Sankyo, Inc. Basking Ridge, United States**Join a Legacy of Innovation 110 Years and Counting** · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class ...
-
Director, Biostatistics
2 weeks ago
Daiichi Sankyo Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ou ...
-
Director, Biostatistics
3 weeks ago
Daiichi Sankyo Inc. Basking Ridge, United States**Join a Legacy of Innovation 110 Years and Counting** · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class ...
-
Director, Biostatistics
5 days ago
Regeneron Pharmaceuticals Basking Ridge, United StatesThe Director of Biostatistics provides leadership and guidance as the statistical expert on a project team or within the Oncology Group · In this role, a typical day might include: · This position is for a qualified statistician/biostatistician to support Clinical Biostatistics ...
-
Associate Director, Biostatistics
1 hour ago
System One Basking Ridge, United StatesJob Title: Associate Director, Biostatistics · Client - Global Pharmaceutical Company · Location: Remote, US Based only - must reside in EST or CST time zones · Type: Direct Hire - Full time salaried direct with the client · Base Salary: $180k - $195K · Must Haves: Oncology ...
-
Director, Biostatistics
2 weeks ago
Regeneron Pharmaceuticals Basking Ridge, United StatesDirector, Biostatistics Early Clinical Development Gene Therapy The Director of Biostatistics provides leadership and guidance as the statistical expert on a project team or within a therapeutic area. In this role, a typical day might include:This po Clinical, Development, Direct ...
-
Associate Director, Biostatistics
2 weeks ago
Joulé Township of Bernards, United StatesJob Title : Associate Director, Biostatistics · Client - Global Pharmaceutical Company · Location: Remote, US Based only - must reside in EST or CST time zones · Type: Direct Hire - Full time salaried direct with the client ...
-
Associate Director, Biostatistics
2 weeks ago
System One Holdings, LLC Basking Ridge, United StatesJob Title: Associate Director, Biostatistics · Client - Global Pharmaceutical Company · Location: Remote, US Based only - must reside in EST or CST time zones · Type: Direct Hire - Full time salaried direct with the client · Base Salary: $180k - $195K · Must Haves: Oncology le ...
Associate Dir/Director, Biostatistics - New York, United States - Zentalis
Description
Job Description
Job DescriptionSalary: $180-250kJOB SUMMARY:
Responsible for designing, analyzing and implementing a wide range of statistical methods (e.g. interim analyses for futility/efficacy, Bayesian methods, etc) and providing rigorous statistical expertise on projects and protocols in support for clinical development. Partners with CRO, data management, statistical programing teams. Develops SAPs, conducts hands on SAS and R programming including simulations; Develop and QCs SDTM/ADaM datasets, tables listings and figures. Develops and adheres to statistical SOPs. Help to maximize the value of clinical trials and real-world data in support of drug development and other scientific strategies. Partners with clinical project and study teams as appropriate. This role will help with critical data interpretations used for internal decision-making and health authority interactions.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
KNOWLEDGE/SKILLS/ABILITIES REQUIRED: