Elan Solutions Inc
Statistical Programming Manager (Full Time, 100% Remote)
Elan Solutions Inc, New York, New York, United States,
Job Description:
Title: Manager, Statistical Programming Manager (Full Time, 100% Remote)
Client: CRO
Location:
Remote (Bay Area)
Salary Range:
$150,000 - $153,800
Must Have:CRO experience of 5+ yearsStudy Lead experience of 3+ yearsPersonnel Management experience of 3+ yearsWork in Pacific Time Zone (
8 hours in an East to West coast time frame)Diverse therapeutic areas experienceExcellent oral and written communication
Overview:
We are seeking a Statistical Programming Manager with extensive CRO and clinical experience for a CRO client, located in the Bay Area. Ideal candidate will be a highly motivated and detail-oriented professional. Please reach out to us if you experience matches below
Responsibilities:Act as the lead for statistical programming on products and/or groups of studies, serving as the main contact for all programmer communications and overseeing task assignments.Independently support statisticians in planned and ad hoc analyses, showcasing SAS programming proficiency.Write and execute statistical programs to create analysis databases, tables, listings, and figures for clinical trial reports.Oversee programming resources across multiple studies, serving as a key resource for other statistical programming leads.Offer timely support to study teams on programming matters according to project strategies, ensuring the integrity of data and on-time deliverables.Execute programming and project standards to support the production or validation of CDISC SDTM, ADaM datasets, and other deliverables.Ensure adherence to quality control procedures for all statistical programming activities.Assist in the development, implementation, maintenance, and testing/validation of the SAS macro library and other utility code/tools to improve statistical programming efficiency.Develop and maintain programming procedures to implement and standardize CDISC and other regulatory requirements.Engage in initiatives aimed at enhancing biostatistical programming processes.Contribute to the development of plans for biostatistical programming, including structure, workflow, standardization, productivity enhancement, and future development.Provide mentoring and support to other statistical programmers.Contribute to the development and maintenance of Standard Operating Procedures (SOPs) and training guidelines for statistical programming.Participate in internal study team and client meetings as required.Education and Experience Requirements:
Degree:
B.S. or B.A. in computer science, statistics, or a related scientific discipline.Experience:
Minimum of 12 years of SAS programming experience, with at least 6 experience handling clinical study data in a contract research organization or pharmaceutical/biotech company.Knowledge & Skill Requirements:
Advanced knowledge of SAS Base, SAS Stat, SAS Macro, and SAS Graph.Proficient in CDISC standards and regulatory submission requirements.Familiarity with other programming languages such as R or Python is a plus.Demonstrated experience in preparing, processing, and analyzing clinical data through SAS code or macros.Experience across all phases of studies, including submissions.Exposure to multiple therapeutic areas and indications.Ability to process clinical data required for statistical analysis and support the creation of summary tables, data listings, graphs, and CDISC datasets for regulatory submission.Minimum of 4 years of personnel management experience.Capability to manage multiple projects with competing and stringent deadlines.Excellent oral and written communication skills.Ability to work effectively in a collaborative and multidisciplinary environment.
Required Skills:• Personnel Management• Graphs• SAS• Regulatory Requirements• Salary• Mentoring• Validation• Programming Languages• Deliverables• R• Statistics• Quality Control• Programming• Databases• Computer Science• Education• Research• Python• Testing• Maintenance• Communication• Science• Training• Management
Title: Manager, Statistical Programming Manager (Full Time, 100% Remote)
Client: CRO
Location:
Remote (Bay Area)
Salary Range:
$150,000 - $153,800
Must Have:CRO experience of 5+ yearsStudy Lead experience of 3+ yearsPersonnel Management experience of 3+ yearsWork in Pacific Time Zone (
8 hours in an East to West coast time frame)Diverse therapeutic areas experienceExcellent oral and written communication
Overview:
We are seeking a Statistical Programming Manager with extensive CRO and clinical experience for a CRO client, located in the Bay Area. Ideal candidate will be a highly motivated and detail-oriented professional. Please reach out to us if you experience matches below
Responsibilities:Act as the lead for statistical programming on products and/or groups of studies, serving as the main contact for all programmer communications and overseeing task assignments.Independently support statisticians in planned and ad hoc analyses, showcasing SAS programming proficiency.Write and execute statistical programs to create analysis databases, tables, listings, and figures for clinical trial reports.Oversee programming resources across multiple studies, serving as a key resource for other statistical programming leads.Offer timely support to study teams on programming matters according to project strategies, ensuring the integrity of data and on-time deliverables.Execute programming and project standards to support the production or validation of CDISC SDTM, ADaM datasets, and other deliverables.Ensure adherence to quality control procedures for all statistical programming activities.Assist in the development, implementation, maintenance, and testing/validation of the SAS macro library and other utility code/tools to improve statistical programming efficiency.Develop and maintain programming procedures to implement and standardize CDISC and other regulatory requirements.Engage in initiatives aimed at enhancing biostatistical programming processes.Contribute to the development of plans for biostatistical programming, including structure, workflow, standardization, productivity enhancement, and future development.Provide mentoring and support to other statistical programmers.Contribute to the development and maintenance of Standard Operating Procedures (SOPs) and training guidelines for statistical programming.Participate in internal study team and client meetings as required.Education and Experience Requirements:
Degree:
B.S. or B.A. in computer science, statistics, or a related scientific discipline.Experience:
Minimum of 12 years of SAS programming experience, with at least 6 experience handling clinical study data in a contract research organization or pharmaceutical/biotech company.Knowledge & Skill Requirements:
Advanced knowledge of SAS Base, SAS Stat, SAS Macro, and SAS Graph.Proficient in CDISC standards and regulatory submission requirements.Familiarity with other programming languages such as R or Python is a plus.Demonstrated experience in preparing, processing, and analyzing clinical data through SAS code or macros.Experience across all phases of studies, including submissions.Exposure to multiple therapeutic areas and indications.Ability to process clinical data required for statistical analysis and support the creation of summary tables, data listings, graphs, and CDISC datasets for regulatory submission.Minimum of 4 years of personnel management experience.Capability to manage multiple projects with competing and stringent deadlines.Excellent oral and written communication skills.Ability to work effectively in a collaborative and multidisciplinary environment.
Required Skills:• Personnel Management• Graphs• SAS• Regulatory Requirements• Salary• Mentoring• Validation• Programming Languages• Deliverables• R• Statistics• Quality Control• Programming• Databases• Computer Science• Education• Research• Python• Testing• Maintenance• Communication• Science• Training• Management