Senior/Principal Statistician Consultant - Phase III Oncology (Remote)
ClinChoice · United States · 1 mo ago
RemoteRemoteAnalystContract
We need to output HTML fragment with headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must preserve all substantive info, no boilerplate. Remove navigation/legal/EEO etc. Also remove application instructions. So we need to extract content.
Let's parse the posting.
First paragraph: "ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking an experienced Senior/Principal Biostatistician with strong hands-on experience supporting Phase III oncology clinical trials. The ideal candidate will have a solid understanding of oncology study design and statistical methodology, strong SAS skills, and the ability to work independently across multiple concurrent studies. This role will collaborate closely with Statistical Programming and cross-functional teams to support study deliverables, including TFLs, ADaM specifications, interim analyses, and regulatory submissions."
That's about the role. Could be "About the role". We'll put that in
. Let's list them:
- Provide statistical expertise and hands-on support for Phase III oncology clinical trials.
- Contribute to study design, statistical analysis, interpretation of results, and clinical study deliverables.
- Demonstrate a strong understanding of key oncology endpoints, including: Overall Survival (OS) Progression-Free Survival (PFS) Objective Response Rate (ORR) Duration of Response (DoR)
- Apply appropriate methods for censoring and time-to-event analyses.
- Apply and interpret statistical methodologies including: Kaplan-Meier analysis Cox Proportional Hazards models Stratified log-rank tests
- Author, review, and provide input into TFL and ADaM specifications in close collaboration with Statistical Programming.
- Review statistical programming outputs, identify discrepancies, and work collaboratively with programmers to resolve issues.
- Use SAS to independently review outputs and perform data and analysis checks.
- Manage deliverables across multiple concurrent clinical studies, ensuring timelines and quality expectations are met.
- Work independently with minimal supervision and quickly become familiar with study requirements, datasets, and programming outputs.
- Collaborate with Biostatistics, Statistical Programming, Data Management, Clinical, Regulatory, and other cross-functional teams as required.
- Support interim analyses and Independent Data Monitoring Committee (IDMC/DMC) activities, including preparation and review of DMC outputs.
We'll put under
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must preserve all substantive info, no boilerplate. Remove navigation/legal/EEO etc. Also remove application instructions. So we need to extract content.
Let's parse the posting.
First paragraph: "ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking an experienced Senior/Principal Biostatistician with strong hands-on experience supporting Phase III oncology clinical trials. The ideal candidate will have a solid understanding of oncology study design and statistical methodology, strong SAS skills, and the ability to work independently across multiple concurrent studies. This role will collaborate closely with Statistical Programming and cross-functional teams to support study deliverables, including TFLs, ADaM specifications, interim analyses, and regulatory submissions."
That's about the role. Could be "About the role". We'll put that in About the role
with
containing that paragraph. Next: "Key Responsibilities" then bullet list (actually sentences separated by periods). We'll convert each sentence to
Responsibilities
with- .
Next: "Required Qualifications" list. Let's extract each bullet:
- Advanced degree (MS, PhD, or equivalent) in Statistics, Biostatistics, or a related quantitative field.
- Direct hands-on experience supporting at least one Phase III oncology clinical trial.
- Strong understanding of oncology clinical trial endpoints, including OS, PFS, ORR, and DoR.
- Strong knowledge of censoring rules and time-to-event analysis.
- Hands-on experience with Kaplan-Meier, Cox Proportional Hazards, and stratified log-rank methods.
- Strong SAS programming skills with the ability to review statistical programming outputs and perform independent checks.
- Experience authoring or reviewing TFL and ADaM specifications and collaborating closely with Statistical Programming.
- Strong problem-solving skills with the ability to identify and resolve discrepancies in analysis outputs.
- Ability to work independently, quickly onboard to new studies, and operate effectively with minimal supervision.
- Demonstrated ability to manage deliverables across multiple concurrent clinical trials while maintaining quality and timelines.
- Excellent written and verbal communication skills.
We'll put under
- ... ...
Required Qualifications
maybe "Requirements" or "Qualifications". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we have both Requirements and Qualifications. We need to decide where to put required qualifications vs preferred qualifications. Likely "Required Qualifications" under "Requirements" or "Qualifications". The instruction: Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have both Requirements and Qualifications sections. We'll put required qualifications under "Requirements". Preferred qualifications under "Qualifications". Skills maybe separate? There's a "Key Competencies" list which could be Skills. We'll treat that as Skills.
Thus:
Requirements
with of required qualifications.
Qualifications
with of preferred qualifications.
Preferred qualifications list:
- Experience supporting FDA and/or EMA regulatory submissions.
- Experience with IDMC/DMC activities and interim analyses, including preparation and review of DMC outputs.
- Experience with R programming is a plus.
- Experience working in a CRO, pharmaceutical, or biotechnology environment.
We'll put those.
Next: "Key Competencies" list: Phase III Oncology, Time-to-Event Analysis, Survival Analysis, SAS, TFL and ADaM Specifications, Statistical Programming Collaboration, Clinical Trial Analysis, Regulatory Submissions, IDMC/DMC Support, Multi-Study Project Management, Independent/Self-Directed Work.
We'll put under Skills
with .
Now Benefits, Pay, Schedule: The posting does not mention benefits, pay, schedule. So we should NOT include those sections.
Also we need to include "About ClinChoice" maybe as part of About the role? The "Who will you be working for? About ClinChoice" section includes description of ClinChoice. That's substantive info about the company. Should we include that? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Remove boilerplate, duplicated lines, application instructions. The "About ClinChoice" is not boilerplate; it's description of the company. Should we include it? Possibly under "About the role" or a separate section like "About the company". But allowed headings list does not include "About the company". However we could incorporate it into About the role section. The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says e.g., not exhaustive. But we should stick to those headings. Could we add another heading like "About ClinChoice"? Not in list but maybe allowed? The instruction says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies those are examples; we could add others if needed. However to be safe, we can include the ClinChoice description within About the role paragraph.
Thus About the role paragraph will include both the initial description and the ClinChoice description.
Let's craft About the role paragraph:
"ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking an experienced Senior/Principal Biostatistician with strong hands-on experience supporting Phase III oncology clinical trials. The ideal candidate will have a solid understanding of oncology study design and statistical methodology, strong SAS skills, and the ability to work independently across multiple concurrent studies. This role will collaborate closely with Statistical Programming and cross-functional teams to support study deliverables, including TFLs, ADaM specifications, interim analyses, and regulatory submissions. 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 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."
But note we must remove EEO/equal-opportunity boilerplate. The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. So we should remove the equal opportunity employer statements. That is boilerplate. So we should omit "ClinChoice is an equal opportunity employer..." and the diversity statement. Also the "#contract" at end maybe not needed. Also remove "The Application Process" etc. Also remove "Who will you be working for? About ClinChoice" heading? We'll incorporate the description but remove EEO lines.
Thus we need to keep the ClinChoice description but exclude the EEO lines. Let's extract the ClinChoice description before the EEO:
"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."
We need to keep that. Also there is a line "Our Company Ethos" maybe part of description. We'll keep.
Thus About the role paragraph will combine the initial role description and the ClinChoice description (excluding EEO). We'll ensure no duplication.
Now we need to ensure we don't include any application instructions: "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." Remove.
Also remove "Who will you be working for? About ClinChoice" heading but we keep content.
Now produce HTML.
Structure:
About the role
...combined text...
Responsibilities
Requirements
...
Qualifications
...
Skills
...
No Benefits, Pay, Schedule.
Make sure to preserve all substantive info: we included all responsibilities, required qualifications, preferred qualifications, key competencies.
Check for any missing info: The initial paragraph also mentions "We are seeking a Senior/ Principal Statistician" and "We are seeking an experienced Senior/Principal Biostatistician". Slight duplication but we keep.
Also note "Key Responsibilities Provide statistical expertise and hands-on support for Phase III oncology clinical trials." The original had no period after "
Qualifications
with- of preferred qualifications.
Preferred qualifications list:
- Experience supporting FDA and/or EMA regulatory submissions.
- Experience with IDMC/DMC activities and interim analyses, including preparation and review of DMC outputs.
- Experience with R programming is a plus.
- Experience working in a CRO, pharmaceutical, or biotechnology environment.
We'll put those.
Next: "Key Competencies" list: Phase III Oncology, Time-to-Event Analysis, Survival Analysis, SAS, TFL and ADaM Specifications, Statistical Programming Collaboration, Clinical Trial Analysis, Regulatory Submissions, IDMC/DMC Support, Multi-Study Project Management, Independent/Self-Directed Work.
We'll put under
Skills
with- .
Now Benefits, Pay, Schedule: The posting does not mention benefits, pay, schedule. So we should NOT include those sections.
Also we need to include "About ClinChoice" maybe as part of About the role? The "Who will you be working for? About ClinChoice" section includes description of ClinChoice. That's substantive info about the company. Should we include that? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Remove boilerplate, duplicated lines, application instructions. The "About ClinChoice" is not boilerplate; it's description of the company. Should we include it? Possibly under "About the role" or a separate section like "About the company". But allowed headings list does not include "About the company". However we could incorporate it into About the role section. The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It says e.g., not exhaustive. But we should stick to those headings. Could we add another heading like "About ClinChoice"? Not in list but maybe allowed? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies those are examples; we could add others if needed. However to be safe, we can include the ClinChoice description within About the role paragraph.
Thus About the role paragraph will include both the initial description and the ClinChoice description.
Let's craft About the role paragraph:
"ClinChoice is a global full-service CRO committed to professional growth and a quality-driven “one-team” culture. We are seeking a Senior/ Principal Statistician to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes. We are seeking an experienced Senior/Principal Biostatistician with strong hands-on experience supporting Phase III oncology clinical trials. The ideal candidate will have a solid understanding of oncology study design and statistical methodology, strong SAS skills, and the ability to work independently across multiple concurrent studies. This role will collaborate closely with Statistical Programming and cross-functional teams to support study deliverables, including TFLs, ADaM specifications, interim analyses, and regulatory submissions. 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 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."
But note we must remove EEO/equal-opportunity boilerplate. The instruction says remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. So we should remove the equal opportunity employer statements. That is boilerplate. So we should omit "ClinChoice is an equal opportunity employer..." and the diversity statement. Also the "#contract" at end maybe not needed. Also remove "The Application Process" etc. Also remove "Who will you be working for? About ClinChoice" heading? We'll incorporate the description but remove EEO lines.
Thus we need to keep the ClinChoice description but exclude the EEO lines. Let's extract the ClinChoice description before the EEO:
"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."
We need to keep that. Also there is a line "Our Company Ethos" maybe part of description. We'll keep.
Thus About the role paragraph will combine the initial role description and the ClinChoice description (excluding EEO). We'll ensure no duplication.
Now we need to ensure we don't include any application instructions: "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." Remove.
Also remove "Who will you be working for? About ClinChoice" heading but we keep content.
Now produce HTML.
Structure:
About the role
...combined text...
Responsibilities
Requirements
- ...
Qualifications
- ...
Skills
- ...