Director, Biostatistics job at PTC Therapeutics in Warren, NJ
Title: Director, Biostatistics
Location: Warren United States
Job Description:
Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area.
The Director, Biostatistics provides technical leadership and operational support for the design and implementation of clinical development programs and the associated clinical trials for therapeutic areas and compounds. This includes but is not limited to: identifying optimal study designs, defining data analysis strategies, implementing statistical analysis plans, authoring and implementing statistical analysis plans, interpreting the resulting findings and crafting and communicating key messages to internal audiences and selected key external stakeholders. The incumbent may interact with regulatory agencies on matters related to the data for assigned clinical programs and/or trials.
The incumbent works cross-functionally with internal departments and external resources on Biostatistics related issues.
The Director, Biostatistics, ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses, publications activities, scientific presentations and promotional material
Develops solutions to statistical and data analysis issues for clinical and regulatory. Communicates solutions cross-functionally.
Participates in vendor evaluation, selection, and management.
Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.
Reviews Case Report Forms (CRFs), annotations, and edit checks to ensure capturing of all required data in a way that supports a high-quality database for the planned analyses.
Authors and manages the implementation of statistical analysis plans for clinical studies and integrated summaries for regulatory submissions.
Authors and reviews statistical and outcome sections of study reports and submissions.
Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities.
Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Minimum level of education and years of relevant work experience.
A Master's degree in Statistics or a related statistical discipline and a minimum of 8+ years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
Special knowledge or skills needed and/or licenses or certificates required.
Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies.
Demonstrated understanding and working knowledge of advanced statistical theory and its application in the pharmaceutical/biotechnology industry.
Prior BLA, NDA and/or MAA experience is highly desirable
Hands-on statistical programming skills using SAS and/or R.
Ability to influence without direct authority.
Proficient in Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Special knowledge or skills and/or licenses or certificates preferred.
Excellent understanding of regulatory requirements and guidance documents
Travel requirements
5- 15%
Expected Base Salary Range: $216,800 - $260,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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Location: Warren United States
Job Description:
Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area.
The Director, Biostatistics provides technical leadership and operational support for the design and implementation of clinical development programs and the associated clinical trials for therapeutic areas and compounds. This includes but is not limited to: identifying optimal study designs, defining data analysis strategies, implementing statistical analysis plans, authoring and implementing statistical analysis plans, interpreting the resulting findings and crafting and communicating key messages to internal audiences and selected key external stakeholders. The incumbent may interact with regulatory agencies on matters related to the data for assigned clinical programs and/or trials.
The incumbent works cross-functionally with internal departments and external resources on Biostatistics related issues.
The Director, Biostatistics, ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses, publications activities, scientific presentations and promotional material
Develops solutions to statistical and data analysis issues for clinical and regulatory. Communicates solutions cross-functionally.
Participates in vendor evaluation, selection, and management.
Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.
Reviews Case Report Forms (CRFs), annotations, and edit checks to ensure capturing of all required data in a way that supports a high-quality database for the planned analyses.
Authors and manages the implementation of statistical analysis plans for clinical studies and integrated summaries for regulatory submissions.
Authors and reviews statistical and outcome sections of study reports and submissions.
Participates in due diligence evaluation of design and clinical trial data of external partnerships opportunities.
Performs other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
Minimum level of education and years of relevant work experience.
A Master's degree in Statistics or a related statistical discipline and a minimum of 8+ years of progressively responsible statistical experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment.
Special knowledge or skills needed and/or licenses or certificates required.
Hands-on experience supporting clinical studies, working with clinical teams and interacting with regulatory agencies.
Demonstrated understanding and working knowledge of advanced statistical theory and its application in the pharmaceutical/biotechnology industry.
Prior BLA, NDA and/or MAA experience is highly desirable
Hands-on statistical programming skills using SAS and/or R.
Ability to influence without direct authority.
Proficient in Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Special knowledge or skills and/or licenses or certificates preferred.
Excellent understanding of regulatory requirements and guidance documents
Travel requirements
5- 15%
Expected Base Salary Range: $216,800 - $260,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Apply tot his job
Apply To this Job