Joulé
Job Title:
Director, Biostatistics (Oncology Indication Lead)Full time permanent - Direct with a global pharmaceutical companyLocation:
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 Statistician indication lead for an Oncology trial is required.
Job overview Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision.
This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision.
This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians.
Additionally, this position works under minimal supervision to solve complex project problems.
ResponsibilitiesProtocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR):
Leads statistical activities for very complex studies or an entire project.
Act as statistical expert in the assigned projects.
Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the compound will be submitted, and helps to maximize the success of the drug product.
Serves as project statistician and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted.
Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD).
Drug Development Strategy:
Provides input to the entire development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies' requirements for countries and regions the drug is to be submitted.
Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4.
CRO / Vendor Oversight:
Participates in drafting request for proposal for CRO selection.
Reviews and negotiates baseline budget and timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results.
Ensures timely delivery of high quality deliverables.
Global Health Authority Interaction / Negotiation:
Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor.
Represents statistics function to Health Authorities meetings as needed.
Global BDO Strategy to Improve Drug Development:
Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision.
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)PhD in statistics or biostatistics requiredExperience Qualifications7 or More Years of relevant experience in the pharmaceutical industry requiredTravel Ability to travel up to 20% International travel required #M3About the Company:
Joul Our StoryImpacting lives.
It's in our DNA.
At Joul , we believe our world is filled with possibilities - where character, integrity and commitment drive our purpose.
For over 30 years, Joul has been a trusted partner to industry leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent.
Operating at the forefront of the life sciences arena, Joul 's relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects.
Joul is a System One division.
Joul consists of multiple business lines working together for client success:
scientific, clinical, and healthcare recruiting plus equipment services.
Since our existence, we've excelled in these specialized markets, and in recent years we have further narrowed the Joul brand to exclusively represent these arenas.
Joul 's services are backed by the considerable reach and resources of our parent company, System One.
The Business of ScienceWay back before STEM was a trend, Joul established its roots in scientific and technical disciplines.
We began life as an engineering services firm, but our business has evolved considerably to where it stands today:
A leader in specialized workforce solutions and integrated servicesOne of the top ten largest clinical and scientific staffing firms in the U.
S.
An ISO-certified provider of laboratory and facility supportAn advocate for scientific, clinical, and healthcare clients and candidates alikeNational Reach with Local ExpertiseWorking at the intersection of business and science, we make it easier to recruit and deploy talent for ongoing work and on-demand projects in a host of disciplines.
We're still writing our story, but our future is built on a foundation of quality delivery and personalized service.
Company Size:
100 to 499 employeesIndustry:
Staffing/Employment AgenciesFounded:
0Website:
https:
//www.
jouleinc.
com/.
Estimated Salary: $20 to $28 per hour based on qualifications.
Director, Biostatistics (Oncology Indication Lead)Full time permanent - Direct with a global pharmaceutical companyLocation:
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 Statistician indication lead for an Oncology trial is required.
Job overview Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision.
This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision.
This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians.
Additionally, this position works under minimal supervision to solve complex project problems.
ResponsibilitiesProtocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR):
Leads statistical activities for very complex studies or an entire project.
Act as statistical expert in the assigned projects.
Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the compound will be submitted, and helps to maximize the success of the drug product.
Serves as project statistician and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted.
Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Review the relevant sections of the electronic common technical document (eCTD).
Drug Development Strategy:
Provides input to the entire development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies' requirements for countries and regions the drug is to be submitted.
Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4.
CRO / Vendor Oversight:
Participates in drafting request for proposal for CRO selection.
Reviews and negotiates baseline budget and timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results.
Ensures timely delivery of high quality deliverables.
Global Health Authority Interaction / Negotiation:
Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor.
Represents statistics function to Health Authorities meetings as needed.
Global BDO Strategy to Improve Drug Development:
Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision.
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)PhD in statistics or biostatistics requiredExperience Qualifications7 or More Years of relevant experience in the pharmaceutical industry requiredTravel Ability to travel up to 20% International travel required #M3About the Company:
Joul Our StoryImpacting lives.
It's in our DNA.
At Joul , we believe our world is filled with possibilities - where character, integrity and commitment drive our purpose.
For over 30 years, Joul has been a trusted partner to industry leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent.
Operating at the forefront of the life sciences arena, Joul 's relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects.
Joul is a System One division.
Joul consists of multiple business lines working together for client success:
scientific, clinical, and healthcare recruiting plus equipment services.
Since our existence, we've excelled in these specialized markets, and in recent years we have further narrowed the Joul brand to exclusively represent these arenas.
Joul 's services are backed by the considerable reach and resources of our parent company, System One.
The Business of ScienceWay back before STEM was a trend, Joul established its roots in scientific and technical disciplines.
We began life as an engineering services firm, but our business has evolved considerably to where it stands today:
A leader in specialized workforce solutions and integrated servicesOne of the top ten largest clinical and scientific staffing firms in the U.
S.
An ISO-certified provider of laboratory and facility supportAn advocate for scientific, clinical, and healthcare clients and candidates alikeNational Reach with Local ExpertiseWorking at the intersection of business and science, we make it easier to recruit and deploy talent for ongoing work and on-demand projects in a host of disciplines.
We're still writing our story, but our future is built on a foundation of quality delivery and personalized service.
Company Size:
100 to 499 employeesIndustry:
Staffing/Employment AgenciesFounded:
0Website:
https:
//www.
jouleinc.
com/.
Estimated Salary: $20 to $28 per hour based on qualifications.
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