Job Board.

General Summary:
The Associate Director, Biostatistics will perform sophisticated scientific statistical analyses in support of the company’s Global Medicines Development and Affairs area with minimal guidance and mentoring on new and complex issues. The incumbent will completed work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The incumbent is capable of independent strategic and technical contributions. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Key Duties and Responsibilities:

• Conducts all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations.
• Leads biostatistics projects or major components of a project including work allocation and review.
• May include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
• Manages one or more team members, including their performance and development.
• Possesses an advanced and in-depth understanding of modern drug discovery and development processes.
• Represents Biostatistics as a member of cross functional teams, providing input and specialized technical guidance to elicit meaningful and/or productive outcomes.
•  Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results.
•  Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality.
•  Contributes to clinical study reports (CSRs) and related processes, authoring or co-authoring methodological or study-related publications and posters.
•  Provides input into programming specifications and review.
•  Contributes to external interactions with regulators, payers, review boards, etc.
•  Authors or co-authors methodological or study-related publications and posters.
•  Determines and implements design and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
• Contributes to departmental working group efforts on various advanced technical and operational issues.
• Independently undertakes new and complex issues.
• Completes assigned work in a resourceful, self-sufficient manner, often conceptualizing alternative approaches to achieve desired results.
• Develops breadth of knowledge across related disciplines with a drug developer mindset.

Knowledge and Skills:

• Some prior staff management experience is typical
• In-depth competence with SAS and R statistical software
• In-depth understanding of advanced statistical methods used in drug development
• Ability to show critical thinking with logical problem-solving
• Excellent written and verbal communication skills
• Excels in a team environment
• Collaborates well with non-statisticians
• NDA/MAA experience and direct dealings with USA/European regulators

Education and Experience:

• Ph. D. or master’s degree in Statistics or Biostatistics.
• Typically requires 7 years of experience with a Ph.D. or 10 years of experience with a master’s degree, or the equivalent combination of education and experience.

More information can be found here.

Posted 02/13/23

Department: Real World Statistics and Analytics
General Summary:
The Associate Director, Real World Statistics will overview and perform sophisticated scientific statistical analyses in support of the company’s post-marketing areas for Global Medicines Development and Affairs (GMDA) and Commercial and Strategic Management (CSM), on new and complex issues with minimal guidance and mentoring. He/She will serve Statistics lead role on assigned projects including clinical trials, real world observational studies, market access and reimbursement activities, and other
ad hoc analyses. He/She will complete assigned work in a resourceful, self-sufficient manner and is able to provide alternative approaches to achieve desired results. In addition, the Associate Director is capable of independent strategic and technical contributions. He/She should possess good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Key Duties and Responsibilities:

The Associate Director, Real World Statistics:

• Is responsible for all scientific and operational statistical work for multiple clinical trials and observational studies, or real world data (RWD) investigations.
• May include management, oversight, and strategic directions of one or more projects or major components of a project.
•  Mentors junior personnel, possibly including one or more direct reports.
• May include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.
•  Possesses an advanced and in-depth understanding of modern drug discovery, development, and post-marketing processes.
• Represents Real World Statistics as a member of cross functional teams, providing strategic input and expert technical guidance to team members. Effectively collaborate with multiple stakeholders from Clinical Development, Medical Affairs, Health Economics and Outcome Research (HEOR), and Real World Evidence (RWE) teams.
•  Develops technical leadership and guides project teams to more meaningful and/or productive ends.
• Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops study documents such as Cross-functional Data Review plan, Key Results Memo, and Data Dissemination Plan in order to facilitate the review, summary, and dissemination of key study data/results.
• Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality.
• Contributes to clinical study reports (CSRs) and related processes, authoring or co-authoring methodological or study-related publications and posters.
• Contributes to external interactions with regulators, payers, review boards, etc.
• Authors or co-authors methodological or study-related publications and posters.
• Contributes to departmental working group efforts on various advanced technical and operational issues.

Knowledge and Skills:

•  Competence with SAS and R statistical software
•  Demonstrated understanding of advanced statistical methods used in drug development
•  Ability to show critical thinking with logical problem-solving
•  Excellent written and verbal communication skills
•  Excels in a team environment
•  Collaborates well with non-statisticians

Education and Experience:

• Ph.D. in Biostatistics or related fields and 7 years of relevant work experience, or
• M.S. in Biostatistics and 10 years of relevant work experience

More information can be found here.

Posted 02/13/23

The Director, Biostatistics will independently perform highly scientific statistical functions in support of the company’s Global Medicines Development and Affairs (GMDA) area on new and complex issues. The incumbent will complete work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results if needed. In addition, the Director provides independent strategic and technical contributions. The incumbent possess an excellent knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. As a people manager within the organization, has  financial accountabilities and human resource responsibilities for assigned staff.

Key Responsibilities:

•Directs one or more projects including multiple clinical trials, observational studies, or real world data (RWD) investigations. Also includes presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards.

•Manage a team of direct reports including their performance and development. Mentors project team members and promotes effective team operation and cross-functional collaboration.

•Possesses an expert understanding of modern drug discovery and development processes.

•Represents Biostatistics as a member of cross functional teams, providing strategic input and expert technical guidance to elicit meaningful and/or productive outcomes. Sets the technical and scientific directions of the project(s).

•Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results.

•Leads collaboration with statistical programming and other functions to ensure high quality and technically sound delivery of TFLs.

•Leads or contributes to external interactions with regulators, payers, review boards, etc.

•Authors or co-authors methodological or study-related publications and posters.

•Leads implementation of innovative designs and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.

•Contributes to departmental working group efforts on key various technical and operational issues.

•Independently undertakes new and highly complex issues requiring advanced analytical thought.

•Completes work in a resourceful, self-sufficient manner; conceptualizes alternative, and at times untested, approaches to achieve desired results.

•Maintains and expands in-depth knowledge of related disciplines with a drug developer mindset.

Education & Experience Required:

·   Ph. D. or master’s degree in Statistics or Biostatistics.

·   Typically requires 10 years of experience with a Ph.D. or 13 years of experience with a master’s degree, or the equivalent combination of education and experience.

More information can be found here.

Posted 02/13/23

Principal Biostatistician Job Description

General Summary:
The Principal Biostatistician will perform advanced scientific statistical analyses in support of the company’s Global Medicines Development and Affairs area with some guidance and mentoring on new and complex issues. The incumbent will completed work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results. The incumbent should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Key Duties and Responsibilities:

• Conducts advanced scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations, including the design, development and execution of the technical/statistical infrastructure.
• Possesses an advanced understanding of modern drug discovery and development processes.
• Represents Biostatistics as a member of clinical trial teams, providing input and technical guidance to elicit meaningful and/or productive outcomes.
• With minimal guidance, authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells.
• Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) to facilitate the review, summary, and dissemination of key study data/results.
• Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality.
• Contributes to external interactions with regulators, payers, review boards, etc.
• Develops statistical section of protocols, including sample size estimates and randomization plans.
• Contributes to clinical study reports (CSRs) and related processes. Also authors or co-authors methodological or study-related publications and posters. Provides input into programming specifications and review.
• Implements design and analysis methods at the study level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
• Contributes to departmental working group efforts on various advanced technical and operational issues.
• Undertakes new and complex issues with minimal guidance
• Completes assigned work in a resourceful, self-sufficient manner and creates alternative approaches to achieve desired results if needed.
• Develops breadth of knowledge across related disciplines with a drug developer mindset.

Knowledge and Skills:

• In-depth experience with SAS and R statistical software
• Demonstrated understanding of advanced statistical methods used in drug development
• Ability to show critical thinking with logical problem-solving
• Excellent written and verbal communication skills
• Excels in a team environment
• Collaborates well with non-statisticians

Education and Experience:

• Ph. D. or master’s degree in Statistics or Biostatistics.
• Typically requires 3 years of experience with a Ph.D. or 6 years of experience with a master’s degree, or the equivalent combination of education and experience.

More information can be found here.

Posted 02/13/23

Job Code
10864

Career Track
Professional

Vertex Level
8

Vertex Family Group
Data Analytics & Insights

Vertex Family
Biostatistics

Vertex Sub-Family
Biostatistics

General/Position Summary
In no more than 3 sentences, describe the overall purpose and reason the job exists. Provide a birds-eye view of the overall purpose (nature, level and purpose of job). The summary should state the role the job plays in achieving department, function or company goals or objectives. The Senior Biostatistician II will perform scientific statistical analyses in support of the company’s Global Medicines Development and Affairs area with guidance and mentoring on new and complex issues. The incumbent will complete assigned work in a resourceful manner and create alternative approaches to achieve desired results. The incumbent will develop a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.

Key Duties & Responsibilities
In order of importance, list 6-10 core duties and responsibilities of the job. Provide action-oriented broad descriptions of what the accountability is and why it is critical to the job’s success. Only add accountabilities that take up more than 5-10% of time (not meant to be laundry list). Relates to major, significant or principal functions performed to an end objective or results against which some measurement of performance can be applied.
• Within assigned area, designs, develops and executes the technical/statistical infrastructure for the
conduct and evaluation of clinical trials, observational studies, or real world data (RWD) investigations,
including related areas/activities.
• Participates in regular Study Execution Team (SET) team meetings as the functional representative.
• Works under supervision to author study Statistical Analysis Plans (SAPs), including table, figure, and
listing (TFL) shells, and presentation to Statistical Review Forum (SRF).
• Plans and conducts Cross-functional Data Review (xFDR) , Key Results Memo (KRM), and Data
Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results.
• Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with
good quality. Provides input into programming specifications and review.
• Develops statistical section of protocols, including sample size estimates and randomization plan.
• Contributes to clinical study reports (CSRs) and related processes. May author or co-author
methodological or study-related publications and posters.
• Implements design and analysis methods at the study level and participates in SRF discussions of
studies assigned to others.
• Contributes to departmental working group efforts on various technical and operational issues.
• Seeks guidance and mentoring on new and complex issues
• Completes assigned work in a resourceful manner and creates alternative approaches to achieve
desired results if needed.
• Develops a basic knowledge of related disciplines with a drug developer mindset.

Required Education Level
Minimum level of education needed (B.S in XX, M.S in XX, Ph.D, etc.).
• Ph. D. or master’s degree in Statistics or Biostatistics.

Required Experience
Indicate the typically required experience needed to perform the job. Please indicate “Typically requires XX
years experience or the equivalent combination of education and experience”. Also note any additional
experience required (i.e; supervisory work).
• Typically requires 3 years of experience for those with a master’s degree or the equivalent
combination of education and experience.

Required Knowledge/Skills
Indicate what skills and/or knowledge are truly required (as opposed to ‘nice to have’) to perform job.
• Competence with SAS and R statistical software
• Demonstrated understanding of statistical methods used in drug development
• Ability to show critical thinking with logical problem-solving
• Excellent written and verbal communication skills
• Excels in a team environment
• Collaborates well with non-statisticians

More information can be found here.

Posted 02/13/23

Job Code
10920

Career Track
Professional

Vertex Level
7

Vertex Family Group
Data Analytics & Insights

Vertex Family
Statistical Programming

Vertex Sub-Family
Statistical Programming

General/Position Summary
In no more than 3 sentences, describe the overall purpose and reason the job exists. Provide a birds-eye view
of the overall purpose (nature, level and purpose of job). The summary should state the role the job plays in achieving department, function or company goals or objectives. The Senior Statistical Programmer provides Statistical Programming support to clinical sub-teams with supervision on projected related programming task. The Senior Statistical Programmer is proactive about asking questions and proposing suggestions to improve processes. In addition, the Senior Statistical Programmer supports clinical sub-team(s) for a limited number of studies.

Key Duties & Responsibilities
In order of importance, list 6-10 core duties and responsibilities of the job. Provide action-oriented broad descriptions of what the accountability is and why it is critical to the job’s success. Only add accountabilities that take up more than 5-10% of time (not meant to be laundry list). Relates to major, significant or principal functions performed to an end objective or results against which some measurement of performance can be applied.
• Displays basic familiarity with many of the SAS procedures and options commonly used in clinical trial
reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
• Codes SAS programs for applications designed to analyze and report clinical trial data and for
electronic submissions of data in CDlSC format with instruction or input from supervisor
• Performs quality control checks of SAS code and output produced by other Statistical Programmers to
ensure accuracy and consistency within group
• Demonstrates emerging knowledge of clinical development and medical data
• Solves straightforward clinical trial reporting problems and has a proven technical proficiency in
supporting daily operations and ensuring that project tasks are completed accurately and on schedule under supervision
• Demonstrates intermediate knowledge of electronic submissions and CDlSC
• Works with internal staff and external vendors to implement and optimize CDlSC transformation
activities
• Supports daily operations and ensures that project tasks are completed accurately and on schedule

Required Education Level
Minimum level of education needed (B.S in XX, M.S in XX, Ph.D, etc.).
• Bachelors degree in a Scientific Discipline.

Required Experience
Indicate the typically required experience needed to perform the job. Please indicate “Typically requires XX years experience or the equivalent combination of education and experience”. Also note any additional experience required (i.e; supervisory work).
• NA

Required Knowledge/Skills
Indicate what skills and/or knowledge are truly required (as opposed to ‘nice to have’) to perform job.
• Basic SAS
• Effective Communication (written and verbal) skills, especially within area(s) of expertise

Other Requirements
Indicate required certifications, licenses or specialized trainings.

More information can be found here.

Posted 02/13/23

Starting date (flexible): July-December 2023
Funding period: 1-2 years
Mentors: Lu Tian DSc; Vivek Charu MD PhD

Opportunity description: We are seeking a motivated post-doctoral fellow interested in statistical methods related to precision medicine. The ideal fellow will have a PhD in biostatistics, statistics, data science, computer science or a related discipline. The successful candidate with work closely with Dr. Tian and Dr. Charu on the development, implementation and evaluation of statistical methods for heterogenous treatment effect estimation in randomized controlled trials and observational studies. The candidate will have ample opportunity for both methodological research and close collaboration with medical investigators.

Contact: Please email your CV and contact information for three references to vcharu@stanford.edu

Posted 03/02/23

Career Category College Job Job Description HOW MIGHT YOU DEFY IMAGINATION? Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients.

The full job description can be found here: https://amgen.wd1.myworkdayjobs.com/Careers/job/US—California—Thousand-Oaks/Grad-Intern—Health-Economics—Outcomes-Research–Oncology-_R-160703.

Posted 03/13/23