Associate Director, Statistics
AbbVie · Florham Park, NJ · 1 mo ago
AnalystFull-time
We need to output HTML fragment with sections: About the role? Actually we have Company Description, Job Description, Major Job Responsibilities, Qualifications, Additional Information (which includes pay range, benefits). We need to use for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections when posting has real specific content. We need to map content.
We have Company Description (About AbbVie) - maybe not needed as heading? The instruction: "use
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections when posting has real specific content. We need to map content.
We have Company Description (About AbbVie) - maybe not needed as heading? The instruction: "use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." So we can use those headings if content exists. The job title is not to be repeated as heading. We have company description; could be considered "About the role"? Actually "About the role" is typical heading for role description. We have "Job Description" which describes role. So we can put that under About the role
with paragraphs.
Responsibilities: we have "Major Job Responsibilities" content. So Responsibilities
with - items.
Requirements: maybe combine Qualifications? The instruction includes Requirements as a possible heading. We have Qualifications section. Could map to Requirements or Qualifications. Since they list both Requirements and Qualifications as possible headings, we need to decide. The posting has "Qualifications" with education/experience etc. Also there are skills mentioned: "High degree of technical competence and sound communication skills...", "Competence in experimental and RWE study design...", etc. Those could go under Skills. Also there are leadership etc. So we can split: Requirements heading for education/experience; Skills heading for technical and soft skills.
Benefits: Additional Information includes benefits: "We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs." Also mention pay range. So we can have Benefits section with that content. Pay section: we have compensation range description. So we need Pay heading with that content. Schedule: not mentioned, so omit.
We must not include boilerplate like EEO, equal opportunity, etc. Remove those lines. Also remove navigation, cookie, legal, scam-warning, duplicated lines, application instructions. The Additional Information includes a lot of legal text about pay, benefits, etc. We need to preserve substantive information: pay range, benefits, long-term incentive programs. Remove the rest like "Note: No amount of pay is considered to be wages..." etc. Also remove equal opportunity employer lines.
We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to keep the exact pay range description? The posting says: "Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future." However they didn't actually give numbers. There's no actual numbers provided. So the content is just that description, no specific numbers. According to rule: never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. The posting does state a compensation range description but no actual numbers; it's basically a placeholder. Is that considered filler? It says "The compensation range described below is the range of possible base pay compensation..." but no range given. That seems like filler. The instruction says never create Pay section unless posting actually states them. It does state something about compensation range but not actual numbers. Might be considered not specific. Safer to omit Pay section because no actual numbers. However we could include the description as it is substantive? It's more like a disclaimer. The rule says "never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD")". This is similar to "varies". So better to omit Pay section.
Benefits: they state specific benefits: paid time off, medical/dental/vision insurance, 401(k), long-term incentive programs. That's substantive. So include Benefits.
Schedule: not mentioned, omit.
Now we need to output only HTML fragment, no /, no markdown.
We'll structure:
About the role
Company Description ...
Job Description ...
But we might combine company description and job description under About the role. Could split into two paragraphs.
Responsibilities: Responsibilities
- ... each responsibility as separate li.
We need to preserve all substantive info from Major Job Responsibilities. That's a long paragraph with many sentences separated by semicolons. We need to break into list items. Each bullet should capture a duty. We'll need to parse the text.
Major Job Responsibilities text:
"Provide scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug development and life-cycle management strategies for assigned projects; for the design, analysis, and reporting of clinical and other scientific research programs; for generating scientific evidence to support medical affairs strategies; and for interacting with regulatory agencies, medical community, and key opinion leaders (KOLs) regarding the results of these activities.
Direct the development of scientific protocols, ensuring they are scientifically sound, aligned with the product strategy, and meet scientific and/or applicable regulatory needs.
Ensure statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific investigations
Demonstrate an excellent understanding of statistical concepts and methodologies.
Take a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and validity of study results.
Be able to explain statistical concepts to non-statisticians.
Review identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research.
Independently select, evaluate and implement alternative analysis strategies or other recommendations to address these issues.
Evaluate appropriateness of available software for planned analyses and assess needs for potential program development of novel statistical methodology.
Maintain technical skills and increase own knowledge of new statistical methodology or areas of application through scientific literature and attendance at professional meetings.
Present own statistical research or review of the statistical literature at meetings and seminars.
Demonstrates a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices.
In collaboration with MHI, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources for research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.
Evaluate alternatives to traditional randomized clinical trials that make use of real-world databases, e.g. electronic health records, insurance claims databases, and/or registries.
Play a key role in the cross-functional team and ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with the statistical analyses provided.
Ensure timely and quality statistical deliverables.
Assist other MA&HTA Statistics colleagues or represent MA&HTA Statistics in addressing questions at management and/or product review meetings.
Provide in-depth scientific/statistical review for scientific reports and publications.
Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality.
Support/Lead HTA submission for optimal reimbursement and product life-cycle management strategy planning and implementation for assigned projects/indications.
Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs.
Independently develop protocols and statistical analysis plans to fulfil the evidence gaps."
We need to turn each sentence or clause into
- . Might be many. We'll try to capture each distinct responsibility.
We'll produce list items:
- Provide scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug development and life-cycle management strategies for assigned projects; for the design, analysis, and reporting of clinical and other scientific research programs; for generating scientific evidence to support medical affairs strategies; and for interacting with regulatory agencies, medical community, and key opinion leaders (KOLs) regarding the results of these activities.
- Direct the development of scientific protocols, ensuring they are scientifically sound, aligned with the product strategy, and meet scientific and/or applicable regulatory needs.
- Ensure statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific investigations.
- Demonstrate an excellent understanding of statistical concepts and methodologies.
- Take a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and validity of study results.
- Be able to explain statistical concepts to non-statisticians.
- Review identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research.
- Independently select, evaluate and implement alternative analysis strategies or other recommendations to address these issues.
- Evaluate appropriateness of available software for planned analyses and assess needs for potential program development of novel statistical methodology.
- Maintain technical skills and increase own knowledge of new statistical methodology or areas of application through scientific literature and attendance at professional meetings.
- Present own statistical research or review of the statistical literature at meetings and seminars.
- Demonstrates a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices.
- In collaboration with MHI, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources for research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.
- Evaluate alternatives to traditional randomized clinical trials that make use of real-world databases, e.g. electronic health records, insurance claims databases, and/or registries.
- Play a key role in the cross-functional team and ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with the statistical analyses provided.
- Ensure timely and quality statistical deliverables.
- Assist other MA&HTA Statistics colleagues or represent MA&HTA Statistics in addressing questions at management and/or product review meetings.
- Provide in-depth scientific/statistical review for scientific reports and publications.
- Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality.
- Support/Lead HTA submission for optimal reimbursement and product life-cycle management strategy planning and implementation for assigned projects/indications.
- Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs.
- Independently develop protocols and statistical analysis plans to fulfil the evidence gaps.
That seems comprehensive.
Now Qualifications: we have a block: "MS (with at least 10 years of experience) or PhD (with at least 6 years of experience) in Statistics, Biostatistics, or a highly related field.High degree of technical competence and sound communication skills, both oral and written.Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies highly desired.Able to identify data or analytical issues, and provide solutions by either applying own skills and knowledge or seeking help from othersAble to build strong relationships with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quoWilling to learn new knowledge and technology, open-minded and adapting for improvement, enthusiastic about innovation and a self-starter to make possibilities real. Strong leadership skills and experience in managing a programming group. Experience in working/managing cross-cultural or oversea teams.Pharmaceutical or related industry experience required, including experience and understanding of drug development and life-cycle management in the regulated
About the role
with paragraphs. Responsibilities: we have "Major Job Responsibilities" content. SoResponsibilities
with- items.
Requirements: maybe combine Qualifications? The instruction includes Requirements as a possible heading. We have Qualifications section. Could map to Requirements or Qualifications. Since they list both Requirements and Qualifications as possible headings, we need to decide. The posting has "Qualifications" with education/experience etc. Also there are skills mentioned: "High degree of technical competence and sound communication skills...", "Competence in experimental and RWE study design...", etc. Those could go under Skills. Also there are leadership etc. So we can split: Requirements heading for education/experience; Skills heading for technical and soft skills.
Benefits: Additional Information includes benefits: "We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs." Also mention pay range. So we can have Benefits section with that content. Pay section: we have compensation range description. So we need Pay heading with that content. Schedule: not mentioned, so omit.
We must not include boilerplate like EEO, equal opportunity, etc. Remove those lines. Also remove navigation, cookie, legal, scam-warning, duplicated lines, application instructions. The Additional Information includes a lot of legal text about pay, benefits, etc. We need to preserve substantive information: pay range, benefits, long-term incentive programs. Remove the rest like "Note: No amount of pay is considered to be wages..." etc. Also remove equal opportunity employer lines.
We need to preserve ALL substantive information; do not invent or summarize away detail. So we need to keep the exact pay range description? The posting says: "Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future." However they didn't actually give numbers. There's no actual numbers provided. So the content is just that description, no specific numbers. According to rule: never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. The posting does state a compensation range description but no actual numbers; it's basically a placeholder. Is that considered filler? It says "The compensation range described below is the range of possible base pay compensation..." but no range given. That seems like filler. The instruction says never create Pay section unless posting actually states them. It does state something about compensation range but not actual numbers. Might be considered not specific. Safer to omit Pay section because no actual numbers. However we could include the description as it is substantive? It's more like a disclaimer. The rule says "never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD")". This is similar to "varies". So better to omit Pay section.
Benefits: they state specific benefits: paid time off, medical/dental/vision insurance, 401(k), long-term incentive programs. That's substantive. So include Benefits.
Schedule: not mentioned, omit.
Now we need to output only HTML fragment, no /, no markdown.
We'll structure:
About the role
Company Description ...
Job Description ...
But we might combine company description and job description under About the role. Could split into two paragraphs. Responsibilities:Responsibilities
- ... each responsibility as separate li. We need to preserve all substantive info from Major Job Responsibilities. That's a long paragraph with many sentences separated by semicolons. We need to break into list items. Each bullet should capture a duty. We'll need to parse the text. Major Job Responsibilities text: "Provide scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug development and life-cycle management strategies for assigned projects; for the design, analysis, and reporting of clinical and other scientific research programs; for generating scientific evidence to support medical affairs strategies; and for interacting with regulatory agencies, medical community, and key opinion leaders (KOLs) regarding the results of these activities. Direct the development of scientific protocols, ensuring they are scientifically sound, aligned with the product strategy, and meet scientific and/or applicable regulatory needs. Ensure statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific investigations Demonstrate an excellent understanding of statistical concepts and methodologies. Take a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and validity of study results. Be able to explain statistical concepts to non-statisticians. Review identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. Independently select, evaluate and implement alternative analysis strategies or other recommendations to address these issues. Evaluate appropriateness of available software for planned analyses and assess needs for potential program development of novel statistical methodology. Maintain technical skills and increase own knowledge of new statistical methodology or areas of application through scientific literature and attendance at professional meetings. Present own statistical research or review of the statistical literature at meetings and seminars. Demonstrates a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices. In collaboration with MHI, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources for research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions. Evaluate alternatives to traditional randomized clinical trials that make use of real-world databases, e.g. electronic health records, insurance claims databases, and/or registries. Play a key role in the cross-functional team and ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with the statistical analyses provided. Ensure timely and quality statistical deliverables. Assist other MA&HTA Statistics colleagues or represent MA&HTA Statistics in addressing questions at management and/or product review meetings. Provide in-depth scientific/statistical review for scientific reports and publications. Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality. Support/Lead HTA submission for optimal reimbursement and product life-cycle management strategy planning and implementation for assigned projects/indications. Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans to fulfil the evidence gaps." We need to turn each sentence or clause into
- . Might be many. We'll try to capture each distinct responsibility. We'll produce list items: - Provide scientific and statistical expertise through own efforts and those of her/his staff (if appropriate) for drug development and life-cycle management strategies for assigned projects; for the design, analysis, and reporting of clinical and other scientific research programs; for generating scientific evidence to support medical affairs strategies; and for interacting with regulatory agencies, medical community, and key opinion leaders (KOLs) regarding the results of these activities. - Direct the development of scientific protocols, ensuring they are scientifically sound, aligned with the product strategy, and meet scientific and/or applicable regulatory needs. - Ensure statistical methodology is appropriate and sound, consistent with the objective(s) of the scientific investigations. - Demonstrate an excellent understanding of statistical concepts and methodologies. - Take a leadership role in introducing new/novel statistical methodological approaches into analysis plans which improve the efficiency and validity of study results. - Be able to explain statistical concepts to non-statisticians. - Review identified or anticipated technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research. - Independently select, evaluate and implement alternative analysis strategies or other recommendations to address these issues. - Evaluate appropriateness of available software for planned analyses and assess needs for potential program development of novel statistical methodology. - Maintain technical skills and increase own knowledge of new statistical methodology or areas of application through scientific literature and attendance at professional meetings. - Present own statistical research or review of the statistical literature at meetings and seminars. - Demonstrates a high degree of responsibility in maintaining Statistics department standards, GxP compliance, and best operating practices. - In collaboration with MHI, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources for research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions. - Evaluate alternatives to traditional randomized clinical trials that make use of real-world databases, e.g. electronic health records, insurance claims databases, and/or registries. - Play a key role in the cross-functional team and ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with the statistical analyses provided. - Ensure timely and quality statistical deliverables. - Assist other MA&HTA Statistics colleagues or represent MA&HTA Statistics in addressing questions at management and/or product review meetings. - Provide in-depth scientific/statistical review for scientific reports and publications. - Ensure the accuracy of the statistical component of scientific reports and/or publications with high quality. - Support/Lead HTA submission for optimal reimbursement and product life-cycle management strategy planning and implementation for assigned projects/indications. - Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs. - Independently develop protocols and statistical analysis plans to fulfil the evidence gaps. That seems comprehensive. Now Qualifications: we have a block: "MS (with at least 10 years of experience) or PhD (with at least 6 years of experience) in Statistics, Biostatistics, or a highly related field.High degree of technical competence and sound communication skills, both oral and written.Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies highly desired.Able to identify data or analytical issues, and provide solutions by either applying own skills and knowledge or seeking help from othersAble to build strong relationships with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quoWilling to learn new knowledge and technology, open-minded and adapting for improvement, enthusiastic about innovation and a self-starter to make possibilities real. Strong leadership skills and experience in managing a programming group. Experience in working/managing cross-cultural or oversea teams.Pharmaceutical or related industry experience required, including experience and understanding of drug development and life-cycle management in the regulated