Principal Biostatistician at Hologic
San Diego, CA
About the Job
Principal Biostatistician
Post Date Oct 27, 2020
PURPOSE —to enable healthier lives everywhere, every day —is driven by a PASSION to become global champions for women’s health . We succeed by fulfilling our PROMISE to bring The Science of Sure _®_ to life through product quality,
clinical differentiation, customer relationships and our team’s talent and
engagement.
Our Purpose is simple: to enable healthier lives everywhere, every day. Toward this
end, we offer clinically proven products designed to detect, diagnose andtreat disease and other health conditions that primarily affect women—earlier
and more accurately than ever to provide ever greater certainty and peace of
mind. This focus has fueled our long track record of innovative medicalbreakthroughs across many therapeutic areas—breast health, cervical health, body
composition, gynecologic health, perinatal health, skeletal health and sexual
health—touching the lives of more than 230 million women around the world every year. In
fact, as global champions for women’s health , no company in the world has
done more to fight cervical and breast cancer than Hologic —and we will continue to
challenge ourselves to ensure that future generations of women have access to
our life-savinginnovations.
Of course, none of this would be possible without the talent and passion of our employees. Together, our
collective expertise and dedication to develop and market robust,
science-based certainty, sustain a pipeline of exceptional solutions that
respond to the unmet health and wellness needs of women, families andcommunities. And when we fulfill our purpose and promise to the world, we also fulfill another goal: a business that generates
sustainable global financial growth from which success and prosperity for our
company, employees and investors naturally follow.
Hologic
is seeking a Principal Biostatistician responsible for designing,
monitoring, and analyzing clinical trials as well as solving statistical
problems for R&D, QA, QC and Marketing and Manufacturing.
Duties & Responsibilities:
+ Manages resources, project priorities andtimelines for assigned projects and clinical trials, as well as manages resources across all biostatistics projects.
+ Expert resource for investigating andimplementing complex statistical theory and methods.
+ Key participant in strategy development andcontingency planning.
+ Providesbiostatistical expertise to Clinical Affairs staff; determines appropriatestatistical methods and procedures.
+ Mentors anddirects more junior biostatisticians.
+ Act askey or primary contributor to FDA (and other regulatory) interactions regardingexperimental design and statistical analysis.
+ Designs,documents, tests and implements complex statistical analysis methods incollaboration with Clinical Affairs and other departments.
+ Ensuresbiostatistical methods, equipment and practices are in compliance with currentregulatory regulations and guidelines.
+ Ensuresstatistical integrity of tables/listings/graphs and statistical analyses thatsupport regulatory submissions and formal organizational statements anddocuments such as press releases and annual reports.
+ Maintainsexpertise in state-of-the-art statistical analysis techniques.
+ Workswith other project team members in Clinical Affairs to ensure CRF and databasedesign meets analysis needs.
+ Developsprograms to perform statistical analysis and present results. Work with SAS programmers to ensureappropriate data analysis and presentation is performed.
+ Providesinput on Data Management SOPs and develops Biostatistical SOPs and workinstructions.
+ Writesand/or reviews Statistical Analysis Plans (SAPs) and develops and/or reviewstable/listing/graph shells for statistical analyses and reports.
+ Interfaceswith clinical investigators and scientists to determine protocol design.
+ Writesand/or reviews the statistical and data analysis sections for regulatorysubmissions.
+ Acts asa resource for other departments (e.g., R&D, QA, QC, Marketing,Manufacturing) regarding statistical issues including experimental design,sample size, statistical analysis and interpretation of results.
Qualifications:
+ Advanced knowledge ofCRF and database development, including attribute assignment and logicchecking.
+ Advanced knowledge ofapplicable FDA regulations and policies regarding study design, conduct,monitoring and data analysis software program validation for database designand clinical trial data management.
+ Expert knowledge ofstatistical software packages such as SAS, JMP or R.
+ Expert knowledge ofcommon and highly complex statistical theory and methods for clinical trials,design of experiment and quality control.
+ Knowledge of businessstrategy, product development and risk mitigation.
+ Knowledge of FDAregulatory requirements for IDE, BLA, PMA and 510K submissions.
+ Knowledge of infectiousdisease, cancer, genomics and common public health issues.
+ Good technical writingskills.
Education:
+ BS or MS
+ MS preferred
+ Degree in statistics orclosely related field strongly preferred
Experience:
+ 8-10 years relatedexperience (MS)
+ 10-12 years relatedexperience (BS)
Agency and Third PartyRecruiter Notice:
Agencies that submit a resume to Hologic must have a
current executed Hologic Agency Agreement executed by a member of the Human
Resource Department. In addition Agencies may only submit candidates to
positions for which they have been invited to do so by a Hologic
Recruiter. All resumes must be sent to
the Hologic Recruiter under these terms or they will not be considered.
_Hologic, Inc. is proud to be an Equal Opportunity Employerinclusive of disability and veterans._
Post Date Oct 27, 2020
PURPOSE —to enable healthier lives everywhere, every day —is driven by a PASSION to become global champions for women’s health . We succeed by fulfilling our PROMISE to bring The Science of Sure _®_ to life through product quality,
clinical differentiation, customer relationships and our team’s talent and
engagement.
Our Purpose is simple: to enable healthier lives everywhere, every day. Toward this
end, we offer clinically proven products designed to detect, diagnose andtreat disease and other health conditions that primarily affect women—earlier
and more accurately than ever to provide ever greater certainty and peace of
mind. This focus has fueled our long track record of innovative medicalbreakthroughs across many therapeutic areas—breast health, cervical health, body
composition, gynecologic health, perinatal health, skeletal health and sexual
health—touching the lives of more than 230 million women around the world every year. In
fact, as global champions for women’s health , no company in the world has
done more to fight cervical and breast cancer than Hologic —and we will continue to
challenge ourselves to ensure that future generations of women have access to
our life-savinginnovations.
Of course, none of this would be possible without the talent and passion of our employees. Together, our
collective expertise and dedication to develop and market robust,
science-based certainty, sustain a pipeline of exceptional solutions that
respond to the unmet health and wellness needs of women, families andcommunities. And when we fulfill our purpose and promise to the world, we also fulfill another goal: a business that generates
sustainable global financial growth from which success and prosperity for our
company, employees and investors naturally follow.
Hologic
is seeking a Principal Biostatistician responsible for designing,
monitoring, and analyzing clinical trials as well as solving statistical
problems for R&D, QA, QC and Marketing and Manufacturing.
Duties & Responsibilities:
+ Manages resources, project priorities andtimelines for assigned projects and clinical trials, as well as manages resources across all biostatistics projects.
+ Expert resource for investigating andimplementing complex statistical theory and methods.
+ Key participant in strategy development andcontingency planning.
+ Providesbiostatistical expertise to Clinical Affairs staff; determines appropriatestatistical methods and procedures.
+ Mentors anddirects more junior biostatisticians.
+ Act askey or primary contributor to FDA (and other regulatory) interactions regardingexperimental design and statistical analysis.
+ Designs,documents, tests and implements complex statistical analysis methods incollaboration with Clinical Affairs and other departments.
+ Ensuresbiostatistical methods, equipment and practices are in compliance with currentregulatory regulations and guidelines.
+ Ensuresstatistical integrity of tables/listings/graphs and statistical analyses thatsupport regulatory submissions and formal organizational statements anddocuments such as press releases and annual reports.
+ Maintainsexpertise in state-of-the-art statistical analysis techniques.
+ Workswith other project team members in Clinical Affairs to ensure CRF and databasedesign meets analysis needs.
+ Developsprograms to perform statistical analysis and present results. Work with SAS programmers to ensureappropriate data analysis and presentation is performed.
+ Providesinput on Data Management SOPs and develops Biostatistical SOPs and workinstructions.
+ Writesand/or reviews Statistical Analysis Plans (SAPs) and develops and/or reviewstable/listing/graph shells for statistical analyses and reports.
+ Interfaceswith clinical investigators and scientists to determine protocol design.
+ Writesand/or reviews the statistical and data analysis sections for regulatorysubmissions.
+ Acts asa resource for other departments (e.g., R&D, QA, QC, Marketing,Manufacturing) regarding statistical issues including experimental design,sample size, statistical analysis and interpretation of results.
Qualifications:
+ Advanced knowledge ofCRF and database development, including attribute assignment and logicchecking.
+ Advanced knowledge ofapplicable FDA regulations and policies regarding study design, conduct,monitoring and data analysis software program validation for database designand clinical trial data management.
+ Expert knowledge ofstatistical software packages such as SAS, JMP or R.
+ Expert knowledge ofcommon and highly complex statistical theory and methods for clinical trials,design of experiment and quality control.
+ Knowledge of businessstrategy, product development and risk mitigation.
+ Knowledge of FDAregulatory requirements for IDE, BLA, PMA and 510K submissions.
+ Knowledge of infectiousdisease, cancer, genomics and common public health issues.
+ Good technical writingskills.
Education:
+ BS or MS
+ MS preferred
+ Degree in statistics orclosely related field strongly preferred
Experience:
+ 8-10 years relatedexperience (MS)
+ 10-12 years relatedexperience (BS)
Agency and Third PartyRecruiter Notice:
Agencies that submit a resume to Hologic must have a
current executed Hologic Agency Agreement executed by a member of the Human
Resource Department. In addition Agencies may only submit candidates to
positions for which they have been invited to do so by a Hologic
Recruiter. All resumes must be sent to
the Hologic Recruiter under these terms or they will not be considered.
_Hologic, Inc. is proud to be an Equal Opportunity Employerinclusive of disability and veterans._