BioSpace, Inc.
Senior Manager, Safety Statistical Programming (Remote)
BioSpace, Inc., North Chicago, Illinois, us, 60086
Job Details
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Job Description
The
Safety Statistical Programming Senior Manager
is a strategic leadership role in the emerging field of safety science, providing programming expertise for development of pooled safety data sets and providing technical guidance to team of Statistical Programmers in the research, development, and safety assessment of pharmaceutical products. This role is directly responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data for multiple compounds and indications. The Senior Manager of Statistical Programming (Safety) must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical Operations.
ResponsibilitiesLead the statistical programming activities for one or more compounds/indications or therapeutic areas.Manage a team of statistical programmers and the resource planning for their assigned projects.Ensure timely deliverables, and that quality processes are followed consistently within the projects.Harmonize SDTM and non-standard source data across multiple studies, creation and validation of ADaM and TLFs for all safety deliverables following AbbVies SOPs, department, and project standards.Develop and oversee SAS programs, Product safety data integration plan, metadata, ADaM specifications, ADaM data sets following CDISC standards and Tables, Listings and Figures (TLFs).Lead initiatives, meetings involving cross functional personnel, external vendors and partner company teams.Lead the development of data extraction and transformation automation tools, standard SAS Macros and participates in the development of standard operating procedures and cross-functional process improvement initiatives.Develop and oversee the development of SAS programs for the creation of ADaM data sets following CDISC standards.Develop and oversee the development of SAS programs for the creation of Tables, Listings and Figures.Ensure consistency of ADaM data sets for individual studies and integrated data.Create documentation for regulatory filings including reviewers guides and data definition documents.Lead the development of standard SAS Macros and the development of standard operating procedures.Manage, mentor and create career development plans for assigned staff.Participate in the recruitment and selection of new staff.Be compliant with training requirements.This role can be based remotely within the US (#LI-Remote).
Qualifications
Candidates must have an
MS
in
Statistics, Computer Science
or a related field with
9+ years
of relevant experience (OR BS in Statistics, Computer Science or a related field with
11+
years of relevant experience).
Qualified candidates will also have the following:
A minimum of 2 years
experience leading a team
of statistical programmers.In-depth understanding of SAS programming concepts and techniques related to drug development.Experience in leading multi study data (SDTM/ADaM) integration projects (such as leading submission programming activities involving multiple studies).Experience in leading statistical programming activities supporting IB, DSUR, PSUR, Integrated Summary of Safety (ISS), Annual Safety Reports and/or other safety analysis.Experience in harmonizing clinical study data from multiple studies with diverse study designs, data standards spanning multiple indications.In-depth understanding of CDISC Standards.In-depth understanding of the drug development process, including experience with regulatory filings.At AbbVie, we look for strong
leadership capabilities
and often ask candidates to demonstrate their ability to:
Communicate clearly and effectively, including cross-functionallyBuild strong relationships with a diverse set of stakeholdersSuccessfully manage a project (organization, deliverables, expectations)Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.This job is eligible to participate in our short-term incentiveprograms.This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Job Description
The
Safety Statistical Programming Senior Manager
is a strategic leadership role in the emerging field of safety science, providing programming expertise for development of pooled safety data sets and providing technical guidance to team of Statistical Programmers in the research, development, and safety assessment of pharmaceutical products. This role is directly responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data for multiple compounds and indications. The Senior Manager of Statistical Programming (Safety) must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical Operations.
ResponsibilitiesLead the statistical programming activities for one or more compounds/indications or therapeutic areas.Manage a team of statistical programmers and the resource planning for their assigned projects.Ensure timely deliverables, and that quality processes are followed consistently within the projects.Harmonize SDTM and non-standard source data across multiple studies, creation and validation of ADaM and TLFs for all safety deliverables following AbbVies SOPs, department, and project standards.Develop and oversee SAS programs, Product safety data integration plan, metadata, ADaM specifications, ADaM data sets following CDISC standards and Tables, Listings and Figures (TLFs).Lead initiatives, meetings involving cross functional personnel, external vendors and partner company teams.Lead the development of data extraction and transformation automation tools, standard SAS Macros and participates in the development of standard operating procedures and cross-functional process improvement initiatives.Develop and oversee the development of SAS programs for the creation of ADaM data sets following CDISC standards.Develop and oversee the development of SAS programs for the creation of Tables, Listings and Figures.Ensure consistency of ADaM data sets for individual studies and integrated data.Create documentation for regulatory filings including reviewers guides and data definition documents.Lead the development of standard SAS Macros and the development of standard operating procedures.Manage, mentor and create career development plans for assigned staff.Participate in the recruitment and selection of new staff.Be compliant with training requirements.This role can be based remotely within the US (#LI-Remote).
Qualifications
Candidates must have an
MS
in
Statistics, Computer Science
or a related field with
9+ years
of relevant experience (OR BS in Statistics, Computer Science or a related field with
11+
years of relevant experience).
Qualified candidates will also have the following:
A minimum of 2 years
experience leading a team
of statistical programmers.In-depth understanding of SAS programming concepts and techniques related to drug development.Experience in leading multi study data (SDTM/ADaM) integration projects (such as leading submission programming activities involving multiple studies).Experience in leading statistical programming activities supporting IB, DSUR, PSUR, Integrated Summary of Safety (ISS), Annual Safety Reports and/or other safety analysis.Experience in harmonizing clinical study data from multiple studies with diverse study designs, data standards spanning multiple indications.In-depth understanding of CDISC Standards.In-depth understanding of the drug development process, including experience with regulatory filings.At AbbVie, we look for strong
leadership capabilities
and often ask candidates to demonstrate their ability to:
Communicate clearly and effectively, including cross-functionallyBuild strong relationships with a diverse set of stakeholdersSuccessfully manage a project (organization, deliverables, expectations)Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.This job is eligible to participate in our short-term incentiveprograms.This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html