Planet Pharma
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https://www.propharmagroup.com
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In this exciting role as a Senior Statistician, you will have primary responsibility for statistical aspects of study design and analysis of data from complex clinical studies conducted for regulatory approval or other clinical evidence purposes. This includes responsibility of design of studies, calculating of sample size and power, writing of statistical portions of protocol and statistical analysis plan, review of protocol and case report forms, analysis and interpretation of data, and preparation of relevant sections of regulatory submissions, reports and manuscripts.
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HM Top 3:
Education Required & Years’ Experience Required: Either a Bachelor’s degree + a minimum of 4 years of statistical experience in trial design and data analysis within healthcare OR advanced degree with a minimum of 2 years of statistical experience in trial design and data analysis within healthcare.
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Nice To Have
Responsibilities may include the following and other duties may be assigned. Designs plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety efficacy and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In developmentphase projects prepares the statistical component of protocols which meet project objectives health authority guidelines and clinical trial methodology standards. Develops and/or applies statistical theories methods and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies outcomes and methods used. Provides specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct and the collection management and/or reporting of data.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties . Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decisionmaking.
Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.
Sr Statistician
Minneapolis, MN 55448 US
Posted: 08/22/2023
2023-08-22
2023-10-23
Employment Type:
Contract
Job Category: Data Sciences
Job Number: 580669
Is job remote?: Yes
Country: United States
Job Description
In this exciting role as a Senior Statistician, you will have primary responsibility for statistical aspects of study design and analysis of data from complex clinical studies conducted for regulatory approval or other clinical evidence purposes. This includes responsibility of design of studies, calculating of sample size and power, writing of statistical portions of protocol and statistical analysis plan, review of protocol and case report forms, analysis and interpretation of data, and preparation of relevant sections of regulatory submissions, reports and manuscripts.
Â
HM Top 3:
- Â Advanced programming experience with either R or SAS
- Â Experience as a biostatistician in clinical study methods & execution, keen interest in medical research
- Â Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
Education Required & Years’ Experience Required: Either a Bachelor’s degree + a minimum of 4 years of statistical experience in trial design and data analysis within healthcare OR advanced degree with a minimum of 2 years of statistical experience in trial design and data analysis within healthcare.
Â
Nice To Have
- PHD in statistics/biostatistics or relevant fields
- 2+ years post graduate experience in medical research
- Understanding of statistics and machine learning methods, ability to continue self-learning of technical and non-technical skills
- Demonstrated proficiency in SAS, R or Python and experience with low level languages, including C/C++
- Prior experience in FDA and/or global regulatory submissions
- Experience with adaptive designs, Bayesian modeling, sequential data, computational statistics
- Experience in processing large data from various data sources
- Experience in handling of protected patient health information
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g. ISO, MDD/MDR, CFR)
- Insatiable desire to learn, to innovate, and to challenge themselves for the benefit of patients.
Responsibilities may include the following and other duties may be assigned. Designs plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety efficacy and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to the life cycle of the product. In developmentphase projects prepares the statistical component of protocols which meet project objectives health authority guidelines and clinical trial methodology standards. Develops and/or applies statistical theories methods and software. Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies outcomes and methods used. Provides specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner in trial design and in establishing standards for clinical conduct and the collection management and/or reporting of data.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties . Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decisionmaking.
Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.
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