VP, Biostatistics
for each section heading. Use - for any list of duties/requirements/benefits. Use
for prose.
We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep the details.
We need to format the content appropriately.
Let's extract sections.
Company overview: "At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram."
Job Summary: "As Vice President, Biostatistics within BioCryst Pharmaceuticals, this individual is responsible for the planning and delivery of statistical activities required to support the highest quality design, conduct and analysis of BioCryst-sponsored studies. Having managerial, technical and vendor management responsibilities, this role is responsible for the appropriate use of strategic statistical thinking and methods, and conformance to principles of GCP, as applicable to biostatistics. S/he is also responsible for the identification, evaluation, and implementation of new processes and technologies that align Biostatistics responsibilities. Performance in this role relies on an extensive experience base in study design, regulatory strategy and programming, sound judgment to plan and accomplish goals, and an ability to lead and direct the work of others. A wide scope of creativity and latitude is expected."
We can combine company overview and job summary under About the role.
Responsibilities list: bullet points from "Essential Duties & Responsibilities". Let's extract each bullet:
- Ensures the relevance, adequacy and accuracy of the state-of-the-art statistical methods employed in all BioCryst-sponsored clinical development activities and selected nonclinical studies.
- Oversees statistical activities of regulatory submissions including NDA/BLAs.
- Ensures clinical data processing conformance to relevant regulatory guidelines and Good Clinical Practice.
- Effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design.
- Lead and manage junior biostatistics staff.
- Selection, direction, and supervision/management of CRO/ contract staff for performance of outsourced operational activities.
- Utilizes statistical software (SAS, EAST, R) for internal ad hoc requests for data analysis, samples sizes, etc.
- Participation in clinical development/product management teams in support of organizational objectives.
- Participation in FDA and other regulatory agency meetings as the Company’s spokesperson for biostatistical topics.
- Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement.
- Definition, monitoring, and evaluation of relevant performance metrics.
- Author/ reviewer of relevant sections of all critical documents required to support development of Company’s products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts and manuscripts.
- Responsible and accountable for accuracy of all data included in public corporate communications of BioCryst clinical trial results, including press releases, slide presentations, SEC filings, scientific meeting abstracts, and published manuscripts.
- Responsible for monitoring of quality audit process for those communications.
- Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor.
Note: Some of these may be more like skills; but they are duties.
Now Experience & Qualifications section: Let's extract:
"Ph.D. in Biostatistics (or related field) with at least 18 years’ experience in the pharmaceutical industry, 10 or more years’ experience in the design, analysis and interpretation of clinical trials or an equivalent combination of education and experience.
At least 5 years of people management and leadership role.
Knowledge and expertise in modern adaptive clinical trial designs, multiplicity testing methods, real world evidence and quantitative decision making.
NDA/BLA filing experience: key contributor to multiple successful product approvals.
Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, including development and accountability for relevant quality management systems.
Experience with Data Monitoring Committees and/or study steering committees.
Takes a hands-on approach (e.g. will do analysis of him/herself when necessary).
Excellent written and verbal communication skills.
Proven team player with ability to work well in a collegial environment: willing to challenge the status quo.
Experience with global regulatory agencies.
Formal expertise and experience in Bayesian statistics as well as frequentist statistics.
“Small-company attitude” that embraces change within a high-risk environment."
Also there is a disclaimer: "The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time." That's boilerplate; we should remove.
Also EEO statements: remove.
Thus we need to split into sections: Requirements (education/experience baseline), Qualifications (specific expertise), Skills (communication, team player, etc). But the instruction says we can use those headings; we need to decide what goes where.
We could put:
- Requirements: Ph.D. in Biostatistics (or related field) with at least 18 years’ experience in the pharmaceutical industry, 10 or more years’ experience in the design, analysis and interpretation of clinical trials or an equivalent combination of education and experience. At least 5 years of people management and leadership role.
- Qualifications: Knowledge and expertise in modern adaptive clinical trial designs, multiplicity testing methods, real world evidence and quantitative decision making. NDA/BLA filing experience: key contributor to multiple successful product approvals. Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, including development and accountability for relevant quality management systems. Experience with Data Monitoring Committees and/or study steering committees. Takes a hands-on approach (e.g. will do analysis of him/herself when necessary). Experience with global regulatory agencies. Formal expertise and experience in Bayesian statistics as well as frequentist statistics. “Small-company attitude” that embraces change within a high-risk environment.
- Skills: Excellent written and verbal communication skills. Proven team player with ability to work well in a collegial environment: willing to challenge the status quo. Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor. (Note that last ability appears also in responsibilities; but we can include under Skills.)
We must not duplicate content; but it's okay if appears in multiple sections? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we need to keep each piece somewhere. If we split, we must ensure we don't lose any. We can include the communication ability under Skills; also it's in responsibilities but we can keep it there as well? Might duplicate but that's okay as long as we preserve. However better to keep each piece only once to avoid redundancy but not required. We'll try to avoid duplication.
Let's list all substantive pieces:
Company overview (about company)
Job summary (role purpose)
Responsibilities list (15 items)
Education/Experience baseline (Ph.D., 18 years, 10 years, 5 years people management)
Knowledge/expertise (adaptive designs, multiplicity, RWE, quantitative decision making)
NDA/BLA filing experience (key contributor)
Proven expertise with disciplines, practices, procedures (quality management systems)
Experience with DMC/steering committees
Hands-on approach
Experience with global regulatory agencies
Formal expertise in Bayesian and frequentist statistics
Small-company attitude
Excellent written and verbal communication skills
Proven team player with ability to work well in collegial environment: willing to challenge status quo
Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor (this appears also in responsibilities but we can keep under Skills)
Now we need to output HTML.
We'll wrap each section in
heading then content.
For About the role: we can put a
containing company overview and job summary combined maybe two paragraphs.
Better: two
elements: one for company overview, one for job summary.
Responsibilities:
- each duty.
Requirements: maybe
- for each bullet: Ph.D..., 18 years..., 10 years..., 5 years people management.
Qualifications:
- for each bullet: knowledge/expertise..., NDA/BLA..., proven expertise..., experience with DMC..., hands-on approach..., experience with global regulatory agencies..., formal expertise Bayesian/frequentist..., small-company attitude.
Skills:
- for each bullet: excellent written and verbal communication skills, proven team player..., ability to communicate technical concepts...
Check for any missing: Did we include "Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor." Yes under Skills.
Now ensure we didn't miss any duty: "Utilizes statistical software (SAS, EAST, R) for internal ad hoc requests for data analysis, samples sizes, etc." included.
"Participation in clinical development/product management teams in support of organizational objectives." included.
"Participation in FDA and other regulatory agency meetings as the Company’s spokesperson for biostatistical topics." included.
"Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement." included.
"Definition, monitoring, and evaluation of relevant performance metrics." included.
"Author/ reviewer of relevant sections of all critical documents required to support development of Company’s products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts and manuscripts." included.
"Responsible and accountable for accuracy of all data included in public corporate communications of BioCryst clinical trial results, including press releases, slide presentations, SEC filings, scientific meeting abstracts, and published manuscripts." included.
"Responsible for monitoring of quality audit process for those communications." included.
Now check if any duty about "Ensures the relevance, adequacy and accuracy of the state-of-the-art statistical methods employed in all
for prose. We need to preserve all substantive information; do not invent or summarize away detail. So we need to keep the details. We need to format the content appropriately. Let's extract sections. Company overview: "At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram." Job Summary: "As Vice President, Biostatistics within BioCryst Pharmaceuticals, this individual is responsible for the planning and delivery of statistical activities required to support the highest quality design, conduct and analysis of BioCryst-sponsored studies. Having managerial, technical and vendor management responsibilities, this role is responsible for the appropriate use of strategic statistical thinking and methods, and conformance to principles of GCP, as applicable to biostatistics. S/he is also responsible for the identification, evaluation, and implementation of new processes and technologies that align Biostatistics responsibilities. Performance in this role relies on an extensive experience base in study design, regulatory strategy and programming, sound judgment to plan and accomplish goals, and an ability to lead and direct the work of others. A wide scope of creativity and latitude is expected." We can combine company overview and job summary under About the role. Responsibilities list: bullet points from "Essential Duties & Responsibilities". Let's extract each bullet: - Ensures the relevance, adequacy and accuracy of the state-of-the-art statistical methods employed in all BioCryst-sponsored clinical development activities and selected nonclinical studies. - Oversees statistical activities of regulatory submissions including NDA/BLAs. - Ensures clinical data processing conformance to relevant regulatory guidelines and Good Clinical Practice. - Effectively contributes to the formulation of clinical development strategies as regards optimal development program and study design. - Lead and manage junior biostatistics staff. - Selection, direction, and supervision/management of CRO/ contract staff for performance of outsourced operational activities. - Utilizes statistical software (SAS, EAST, R) for internal ad hoc requests for data analysis, samples sizes, etc. - Participation in clinical development/product management teams in support of organizational objectives. - Participation in FDA and other regulatory agency meetings as the Company’s spokesperson for biostatistical topics. - Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement. - Definition, monitoring, and evaluation of relevant performance metrics. - Author/ reviewer of relevant sections of all critical documents required to support development of Company’s products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts and manuscripts. - Responsible and accountable for accuracy of all data included in public corporate communications of BioCryst clinical trial results, including press releases, slide presentations, SEC filings, scientific meeting abstracts, and published manuscripts. - Responsible for monitoring of quality audit process for those communications. - Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor. Note: Some of these may be more like skills; but they are duties. Now Experience & Qualifications section: Let's extract: "Ph.D. in Biostatistics (or related field) with at least 18 years’ experience in the pharmaceutical industry, 10 or more years’ experience in the design, analysis and interpretation of clinical trials or an equivalent combination of education and experience. At least 5 years of people management and leadership role. Knowledge and expertise in modern adaptive clinical trial designs, multiplicity testing methods, real world evidence and quantitative decision making. NDA/BLA filing experience: key contributor to multiple successful product approvals. Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, including development and accountability for relevant quality management systems. Experience with Data Monitoring Committees and/or study steering committees. Takes a hands-on approach (e.g. will do analysis of him/herself when necessary). Excellent written and verbal communication skills. Proven team player with ability to work well in a collegial environment: willing to challenge the status quo. Experience with global regulatory agencies. Formal expertise and experience in Bayesian statistics as well as frequentist statistics. “Small-company attitude” that embraces change within a high-risk environment." Also there is a disclaimer: "The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time." That's boilerplate; we should remove. Also EEO statements: remove. Thus we need to split into sections: Requirements (education/experience baseline), Qualifications (specific expertise), Skills (communication, team player, etc). But the instruction says we can use those headings; we need to decide what goes where. We could put: - Requirements: Ph.D. in Biostatistics (or related field) with at least 18 years’ experience in the pharmaceutical industry, 10 or more years’ experience in the design, analysis and interpretation of clinical trials or an equivalent combination of education and experience. At least 5 years of people management and leadership role. - Qualifications: Knowledge and expertise in modern adaptive clinical trial designs, multiplicity testing methods, real world evidence and quantitative decision making. NDA/BLA filing experience: key contributor to multiple successful product approvals. Proven expertise with the disciplines, practices and procedures that pertain to biostatistics, including development and accountability for relevant quality management systems. Experience with Data Monitoring Committees and/or study steering committees. Takes a hands-on approach (e.g. will do analysis of him/herself when necessary). Experience with global regulatory agencies. Formal expertise and experience in Bayesian statistics as well as frequentist statistics. “Small-company attitude” that embraces change within a high-risk environment. - Skills: Excellent written and verbal communication skills. Proven team player with ability to work well in a collegial environment: willing to challenge the status quo. Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor. (Note that last ability appears also in responsibilities; but we can include under Skills.) We must not duplicate content; but it's okay if appears in multiple sections? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we need to keep each piece somewhere. If we split, we must ensure we don't lose any. We can include the communication ability under Skills; also it's in responsibilities but we can keep it there as well? Might duplicate but that's okay as long as we preserve. However better to keep each piece only once to avoid redundancy but not required. We'll try to avoid duplication. Let's list all substantive pieces: Company overview (about company) Job summary (role purpose) Responsibilities list (15 items) Education/Experience baseline (Ph.D., 18 years, 10 years, 5 years people management) Knowledge/expertise (adaptive designs, multiplicity, RWE, quantitative decision making) NDA/BLA filing experience (key contributor) Proven expertise with disciplines, practices, procedures (quality management systems) Experience with DMC/steering committees Hands-on approach Experience with global regulatory agencies Formal expertise in Bayesian and frequentist statistics Small-company attitude Excellent written and verbal communication skills Proven team player with ability to work well in collegial environment: willing to challenge status quo Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor (this appears also in responsibilities but we can keep under Skills) Now we need to output HTML. We'll wrap each section in
heading then content. For About the role: we can put a
containing company overview and job summary combined maybe two paragraphs. Better: two
elements: one for company overview, one for job summary. Responsibilities:
- each duty.
Requirements: maybe
- for each bullet: Ph.D..., 18 years..., 10 years..., 5 years people management.
Qualifications:
- for each bullet: knowledge/expertise..., NDA/BLA..., proven expertise..., experience with DMC..., hands-on approach..., experience with global regulatory agencies..., formal expertise Bayesian/frequentist..., small-company attitude.
Skills:
- for each bullet: excellent written and verbal communication skills, proven team player..., ability to communicate technical concepts... Check for any missing: Did we include "Ability to communicate technical concepts to technical or regulatory audiences, and to broader audiences in a nontechnical manner without loss of rigor." Yes under Skills. Now ensure we didn't miss any duty: "Utilizes statistical software (SAS, EAST, R) for internal ad hoc requests for data analysis, samples sizes, etc." included. "Participation in clinical development/product management teams in support of organizational objectives." included. "Participation in FDA and other regulatory agency meetings as the Company’s spokesperson for biostatistical topics." included. "Participation in organization-wide process definition, creation, and implementation with a continuous focus on efficiency and productivity enhancement." included. "Definition, monitoring, and evaluation of relevant performance metrics." included. "Author/ reviewer of relevant sections of all critical documents required to support development of Company’s products including clinical study protocols, statistical analysis plans, data management plans, regulatory briefing documents, regulatory dossiers such as NDAs and MAAs, responses to regulatory questions, scientific abstracts and manuscripts." included. "Responsible and accountable for accuracy of all data included in public corporate communications of BioCryst clinical trial results, including press releases, slide presentations, SEC filings, scientific meeting abstracts, and published manuscripts." included. "Responsible for monitoring of quality audit process for those communications." included. Now check if any duty about "Ensures the relevance, adequacy and accuracy of the state-of-the-art statistical methods employed in all
- for each bullet: knowledge/expertise..., NDA/BLA..., proven expertise..., experience with DMC..., hands-on approach..., experience with global regulatory agencies..., formal expertise Bayesian/frequentist..., small-company attitude.
Skills:
- for each bullet: Ph.D..., 18 years..., 10 years..., 5 years people management.
Qualifications: