Director Biostatistics Hematology

Waltham, MA - USA

Monthly Salary: Not Disclosed

Posted on: 2 days ago

Vacancies: 1 Vacancy

Job Summary

The Director Biostatistics leads the full scope of statistical contribution to a clinical development program including life cycle management. The AD provides for statistical excellence in clinical development plans trial planning data analysis interpretation and reporting and regulatory interactions and submissions while partnering closely with Clinical Development and other key stakeholders.

Responsibilities and Accountabilities:

Define the statistical strategy and ensure appropriate statistical methodologies applied to the clinical development plan study design and data analysis for clinical trials and regulatory submissions.

Provide statistical insight into execution of clinical development to ensure study conduct leads to a statistically sound and robust data package maximize probability of program success.

Interprets analysis results and ensures reporting accuracy in study reports and regulatory documents abstracts posters oral presentations manuscripts and written reports to effectively communicate results of clinical programs and studies.

May serve as the point of contact for one or more PSTs within the TA.

Lead or provide oversight to the analysis delivery and quantitative evaluation of clinical trials and integrated analysis.

Represent Biostatistics in interactions with regulatory authorities (eg FDA EMA PMDA) which includes leading written responses to regulatory questions and attending regulatory meetings.

Qualifications:

Education

PhD or MS/MA in statistics or related field

Experience

10 years of experience in clinical development within the pharmaceutical or biotechnology industry

Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions

Experience partnering with cross-functional teams and interacting with health authorities

Experience managing external partners (CROs consultants)

Competencies

Strong statistical methodology knowledge and clinical trial design expertise

Ability to collaborate and influence across functions and levels

Excellent communication and interpersonal skills

Experience with CDISC standards programming oversight and statistical operations

Strategic and analytical mindset with a focus on execution

Ability to work in a matrixed environment and lead through influence

Working Conditions

This is a hybrid position. Three in-office days per week are required.

Travel Requirements

Occasional travel to scientific conventions

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

Director