Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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ASSOICIATE DIRECTOR, BIOSTATISTICS
395 Oyster Point Blvd, , Suite 217 South San Francisco, CA 94080 US
Posted: 08/26/2024
2024-08-26
2024-10-11
Employment Type:
Direct Hire/Perm
Job Category: Data Sciences
Job Number: 614105
Is job remote?: No
Country: United States
Job Description
ASSOICIATE DIRECTOR, BIOSTATISTICS
POSITION SUMMARY:
As the Associate Director of Biostatistics you will work in collaboration with the Head of Biostatistics to provide statistical support for multiple projects. This hire will be responsible for serving as the Statistical representative among our cross-functional teams to contribute to the design & execution of clinical studies; will also be responsible for managing, planning, and tracking the Statistical activities and coordinating the external statistical FSP and internal resource to ensure corporate, and departmental goals are met. This role will report to the Head of Biostatistics.
This position has a preference for being located in the San Francisco Bay or Boston, however, has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Serves as study statistician for clinical trials; develop trial design options and provide high quality decision support
· Evaluate and implement innovative designs and novel statistical methodologies as appropriate for clinical studies
· Act as the primary contact and provide oversight for all statistical related activities outsourced to CROs and external vendors. Work collaboratively with CRO vendors, Clinical Research, Drug Safety, Regulatory, Clinical Operation, and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
· Applies knowledge of regulatory requirements regarding statistical principles to ensure the company meets its regulatory, scientific, and business objectives
· Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company
· Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed
· Prepare and/or review in detail the Statistical Analysis Plan (SAP) including development of standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs (including review of work by programmers), as well as preparation of the clinical study report
· Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications
· Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, TLFs, study reports, manuscripts, and regulatory submission documents
· Oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical studies
· Conduct hands-on exploratory analyses, sample size computation, modeling and simulation, and create tools to gain meaningful insights from trial data as needed
· Interpret, summarize, and present data and statistical considerations to internal study team, senior management, advisory boarding meetings and global health authorities
· Keep abreast of new developments and advancements in statistics, drug development, science, and regulatory guidance
· Travel may be required (up to 15%)
QUALIFICATIONS
· PhD degree in Statistics/Biostatistics or equivalent with 5+ year of experience in pharmaceutical/biotech (Non-CRO) industry
· Extensive hands-on experience in oncology drug development including design and analysis of both early and late phase oncology trials
· Proven competencies in interaction with health authorities (such as FDA, EMA, PMDA) and eCTD (NDA/BLA) regulatory submissions
· Experience working in a quality regulated environment with a thorough understanding of GCPs
· Excellent programming skills in SAS/R
· Familiarity with industry data standards, including CDISC, SDTM and ADaM data models
· Ability and interest to work cross functionally as a strategic partner
· Self-motivated, flexible and creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment
· Effective communication skills: oral, written, with proven negotiation skills, and strong time-management.
· A critical and logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
· Advanced knowledge of pharmaceutical development across all stages, with the ability to understand and interpret data/information and its practical application.
· Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
· Experience working with external vendors
· Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.
COMPENSATION AND BENEFITS
The salary range for this position is $190,000 - $200,000.
POSITION SUMMARY:
As the Associate Director of Biostatistics you will work in collaboration with the Head of Biostatistics to provide statistical support for multiple projects. This hire will be responsible for serving as the Statistical representative among our cross-functional teams to contribute to the design & execution of clinical studies; will also be responsible for managing, planning, and tracking the Statistical activities and coordinating the external statistical FSP and internal resource to ensure corporate, and departmental goals are met. This role will report to the Head of Biostatistics.
This position has a preference for being located in the San Francisco Bay or Boston, however, has the potential to be fully remote. Occasional travel will be required for in person meetings.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Serves as study statistician for clinical trials; develop trial design options and provide high quality decision support
· Evaluate and implement innovative designs and novel statistical methodologies as appropriate for clinical studies
· Act as the primary contact and provide oversight for all statistical related activities outsourced to CROs and external vendors. Work collaboratively with CRO vendors, Clinical Research, Drug Safety, Regulatory, Clinical Operation, and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting
· Applies knowledge of regulatory requirements regarding statistical principles to ensure the company meets its regulatory, scientific, and business objectives
· Collaborates with study investigators, outside experts, and internal colleagues to present and publish trial results and statistical analyses within and outside of the company
· Review data collection strategies and instruments, database design, edit check specifications, external data transfer specifications, and SDTM mapping as needed
· Prepare and/or review in detail the Statistical Analysis Plan (SAP) including development of standardized well-presented mock-up displays for Tables, Listings, and Figures (TLFs), conduct data analyses, and oversee preparation of all TLFs (including review of work by programmers), as well as preparation of the clinical study report
· Create or review programming specifications for analysis datasets and TLFs, including SDTM and ADaM specifications
· Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, TLFs, study reports, manuscripts, and regulatory submission documents
· Oversee and contribute to the completion of all technical and operational statistical activities for a group of clinical studies
· Conduct hands-on exploratory analyses, sample size computation, modeling and simulation, and create tools to gain meaningful insights from trial data as needed
· Interpret, summarize, and present data and statistical considerations to internal study team, senior management, advisory boarding meetings and global health authorities
· Keep abreast of new developments and advancements in statistics, drug development, science, and regulatory guidance
· Travel may be required (up to 15%)
QUALIFICATIONS
· PhD degree in Statistics/Biostatistics or equivalent with 5+ year of experience in pharmaceutical/biotech (Non-CRO) industry
· Extensive hands-on experience in oncology drug development including design and analysis of both early and late phase oncology trials
· Proven competencies in interaction with health authorities (such as FDA, EMA, PMDA) and eCTD (NDA/BLA) regulatory submissions
· Experience working in a quality regulated environment with a thorough understanding of GCPs
· Excellent programming skills in SAS/R
· Familiarity with industry data standards, including CDISC, SDTM and ADaM data models
· Ability and interest to work cross functionally as a strategic partner
· Self-motivated, flexible and creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment
· Effective communication skills: oral, written, with proven negotiation skills, and strong time-management.
· A critical and logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
· Advanced knowledge of pharmaceutical development across all stages, with the ability to understand and interpret data/information and its practical application.
· Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
· Experience working with external vendors
· Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in an office environment.
COMPENSATION AND BENEFITS
The salary range for this position is $190,000 - $200,000.
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