Senior Statistical Programmer Consultant - Oncology
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
Provide oversight development of datasets (SDTMs/ADaMs) in CDISC compliant format by CROs including clear documentation of the process that was followed in the form of specifications, trackers and checklists.
Generate and/or review of SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents and reviewers’ guides per CDISC and FDA specifications and guidelines.
Accountable for oversight of statistical programming deliverables for inhouse and outsourced projects.
Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
Independently develop SAS or other programs and specifications for production of output to support study needs including publications, safety reporting, ad hoc analyses in a timely fashion
Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
Oversee and manage work of other junior programmers.
Develop and/or validate standard macros to automate output production.
Adhere to company SOPs and department guidelines.
Work concurrently on multiple projects
Troubleshoot technical and project issues.
Help with infrastructure development of the department.
Communicate effectively with internal cross-functional groups and external partners.
QUALIFICATIONS
BS/BA degree in related discipline
At least 8 – 10 years of experience in statistical programming with clinical data and SAS
Experience in oncology therapeutic area required.
Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros
CDISC proficiency required
SAS/GRAPH experience (Kaplan-Meier plots, swim lane plots) strongly preferred
Knowledge of appropriate regulations, industry standards and guidance documents
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways
Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #Senior #Contract
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Senior Statistical Programmer Consultant - Oncology
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:
Provide oversight development of datasets (SDTMs/ADaMs) in CDISC compliant format by CROs including clear documentation of the process that was followed in the form of specifications, trackers and checklists.
Generate and/or review of SDTM mapping specifications, annotated CRFs, ADaM specifications, define.XML documents and reviewers’ guides per CDISC and FDA specifications and guidelines.
Accountable for oversight of statistical programming deliverables for inhouse and outsourced projects.
Provide technical leadership, problem solving of moderate to high complexity and within project timelines while providing high quality deliverables.
Independently develop SAS or other programs and specifications for production of output to support study needs including publications, safety reporting, ad hoc analyses in a timely fashion
Demonstrate expertise in SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT & SAS/GRAPH.
Oversee and manage work of other junior programmers.
Develop and/or validate standard macros to automate output production.
Adhere to company SOPs and department guidelines.
Work concurrently on multiple projects
Troubleshoot technical and project issues.
Help with infrastructure development of the department.
Communicate effectively with internal cross-functional groups and external partners.
QUALIFICATIONS
BS/BA degree in related discipline
At least 8 – 10 years of experience in statistical programming with clinical data and SAS
Experience in oncology therapeutic area required.
Strong SAS programming skills required with proficiency in SAS/Base, SAS/Stat and SAS/Macros
CDISC proficiency required
SAS/GRAPH experience (Kaplan-Meier plots, swim lane plots) strongly preferred
Knowledge of appropriate regulations, industry standards and guidance documents
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways
Good interpersonal communication skills to collaborate effectively with internal cross-functional groups and external partners
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#LI-TT1 #LI-Remote #Senior #Contract