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Senior Manager (Biostatistics)
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Senior Manager (Biostatistics)
role at
Jobs via Dice Get AI-powered advice on this job and more exclusive features. Dice is the leading career destination for tech experts at every stage of their careers. Our client, VISION INFOTECH INC., is seeking the following. Apply via Dice today!
Hi,
Hope you're doing well!!
Please find the requirement below. If you find yourself comfortable with the requirement please reply back with your updated resume or call me back at
Position --- Senior Manager(Biostatistics)
Location --- Woburn, Massachusetts(Hybrid)(Local Consultant)
Duration --- 6+ Months
Client won't be able to sponsor any visa
Pharmaceutical Experience
A pharmaceutical company in Massachusetts is actively seeking a new Senior Manager, Biostatistics to their team. Acting as statistical study lead, the Senior Manager Biostatistics will be responsible for providing technical input and biostatistical support on the design and conduct of clinical studies.
Responsibilities:
Lead in study level tasks, ensuring statistical integrity; contribute strategically to the supporting projects from statistics perspective Contribute to study level tasks from statistics perspective, including study design and sample size determination, protocol statistics section, SAP and DMC charter Review study randomization files and develop TFL shell and specification Review CRFs and other study documentations Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting Independently conduct analyses suggested by the data Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results Contribute to developing standards and research in advanced statistical methodologies Review regulatory documents or scientific publications
Qualifications:
D, in Statistics or Biostatistics with a minimum of 3 years (min 6 years for Master's degree) of post-graduate experience in the Clinical Trials setting in the pharmaceutical industry Experience as or is capable to act as Study Lead Statistician and contribute to strategy discussion in cross functional settings Experience in study level work including authoring SAP and TFL specification Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance Familiar with SAS and R Solid understanding of Mathematical and Statistical principles Detailed-oriented with organization, problem solving and prioritization skills Experience in NDA / BLA / MAA activities as a contributor from statistics perspective and direct involvement in Regulatory interaction Knowledge in CDISC including SDTM, ADaM, and controlled terminologies
Thanks & Regards:
Amar Pratap
Senior Technical Recruiter
VISION INFOTECH INC
Phone: ext 531
Direct:
Email:
368 Main Street, st #3, Melrose MA 02176
E-Verified Company Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Software Development Referrals increase your chances of interviewing at Jobs via Dice by 2x Sign in to set job alerts for “Manager Biostatistics” roles.
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Senior Manager (Biostatistics)
role at
Jobs via Dice 1 day ago Be among the first 25 applicants Join to apply for the
Senior Manager (Biostatistics)
role at
Jobs via Dice Get AI-powered advice on this job and more exclusive features. Dice is the leading career destination for tech experts at every stage of their careers. Our client, VISION INFOTECH INC., is seeking the following. Apply via Dice today!
Hi,
Hope you're doing well!!
Please find the requirement below. If you find yourself comfortable with the requirement please reply back with your updated resume or call me back at
Position --- Senior Manager(Biostatistics)
Location --- Woburn, Massachusetts(Hybrid)(Local Consultant)
Duration --- 6+ Months
Client won't be able to sponsor any visa
Pharmaceutical Experience
A pharmaceutical company in Massachusetts is actively seeking a new Senior Manager, Biostatistics to their team. Acting as statistical study lead, the Senior Manager Biostatistics will be responsible for providing technical input and biostatistical support on the design and conduct of clinical studies.
Responsibilities:
Lead in study level tasks, ensuring statistical integrity; contribute strategically to the supporting projects from statistics perspective Contribute to study level tasks from statistics perspective, including study design and sample size determination, protocol statistics section, SAP and DMC charter Review study randomization files and develop TFL shell and specification Review CRFs and other study documentations Work collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting Independently conduct analyses suggested by the data Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results Contribute to developing standards and research in advanced statistical methodologies Review regulatory documents or scientific publications
Qualifications:
D, in Statistics or Biostatistics with a minimum of 3 years (min 6 years for Master's degree) of post-graduate experience in the Clinical Trials setting in the pharmaceutical industry Experience as or is capable to act as Study Lead Statistician and contribute to strategy discussion in cross functional settings Experience in study level work including authoring SAP and TFL specification Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance Familiar with SAS and R Solid understanding of Mathematical and Statistical principles Detailed-oriented with organization, problem solving and prioritization skills Experience in NDA / BLA / MAA activities as a contributor from statistics perspective and direct involvement in Regulatory interaction Knowledge in CDISC including SDTM, ADaM, and controlled terminologies
Thanks & Regards:
Amar Pratap
Senior Technical Recruiter
VISION INFOTECH INC
Phone: ext 531
Direct:
Email:
368 Main Street, st #3, Melrose MA 02176
E-Verified Company Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Research, Analyst, and Information Technology Industries Software Development Referrals increase your chances of interviewing at Jobs via Dice by 2x Sign in to set job alerts for “Manager Biostatistics” roles.
Senior Director Biostatistics Oncology (People Manager)
Senior Director Biostatistics Oncology (People Manager)
Boston, MA $250,000.00-$300,000.00 2 days ago Boston, MA $235,000.00-$305,000.00 6 days ago Cambridge, MA $217,500.00-$319,000.00 19 hours ago Boston, MA $137,000.00-$215,270.00 5 days ago Boston, MA $220,000.00-$250,000.00 2 weeks ago Associate Director Biostatistics, Cell Therapy Immunology
Boston, MA $137,000.00-$215,270.00 2 weeks ago Associate Medical Director Clinical Development Nephrology
Senior Manager, Clinical Data Management
Clinical Project Manager (CPM)/Sr CPM (Phase I-Hybrid)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr