Sr Principal Statistics
Sr Principal Statistics
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Salary Not Disclosed
1 Vacancy
Job Description
Sr Principal Statistics
Paramus NJ - remote only
must be a US Citizen or green card holder.
6 month contract - no c2c
- The Senior Manager in Statistics responsible for perform statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing regulatory filings and marketing.
RESPONSIBILITIES:
- Review protocol understand study requirements prepare statistical sections design study elements including sample size calculation analysis methods study duration etc.
- Review CRF database design and edit check specs
- Review study quality surveillance plan and monitor study conduct
- Prepare and/or review SAP TFL shells and specifications for variable derivation
- Work closely with Statistical Programmers and Clinical Data Manager in identify data quality issues for key efficacy and safety variables
- Provide statistical and validation support for statistical analysis analysis datasets and TFL Review study report manuscripts and other documents related to statistics
- Work on responses to health authorities and execute new analysis required for responses review statistical inputs for regulatory documents
- Perform other ad-hoc statistical activities as needed
- Works effectively with cross functional groups study team and vendors. Proactively control and monitor timelines related to statistics and statistical programming
- Participates in monitoring CRO activities and reviewing CRO deliverable
- Other duties as assigned
QUALIFICATIONS:
- Education: Ph.D. or MS in Statistics or Biostatistics
- Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience
- Excellent knowledge of SAS computer package
- Excellent knowledge of industry standards such as the ICH guidelines CDISC data structures and FDA guidelines
- Excellent organizational skills time management and ability to meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others
- Exceptional interpersonal skills and problem-solving capabilities
- Ability to work independently and collaboratively
- Ability to provide leadership for the CRO statisticians and statistical programmers
PHYSICAL AND MENTAL REQUIREMENTS:
- Ability to multitask
- Adapts to change
- Maintain composure under pressure
- Ability to follow verbal or written instructions and use of effective verbal communications
- Adapts change adjust change and grasps information quickly
- Examine and observe details
Required Knowledge Skills and Abilities: (Companies ATS Questions):
1. Do you have a Ph.D. or MS in Statistics or Biostatistics
2. Do you have a Minimum of 4 years (Ph. D) or 6 years (MS) Pharmaceutical/CRO industry experience
3. Do you have SAS computer package
4. Do you have a industry standards such as the ICH guidelines CDISC data structures and FDA guidelines
5. Do you have a Strong organizational communication leadership and problem-solving skills with the ability to lead CRO teams and work both independently and collaboratively to meet deadlines.
6. Do you have a Review CRF database design and edit check specs
7. Do you have Prepare and/or review SAP TFL shells and specifications for variable derivation
8. Do you have a Provide statistical and validation support for statistical analysis analysis datasets and TFL Review study report manuscripts and other documents related to statistics
9. Do you have a Work on responses to health authorities and execute new analysis required for responses review statistical inputs for regulatory documents
10. Must be a US Citizen or Green Card holder.
Employment Type
Full Time
