Principal Biostatistician

Posted 3 Days Ago
Be an Early Applicant
Remote
5-7 Years Experience
Pharmaceutical
The Role
Principal Biostatistician at Parexel responsible for providing expertise in statistical methods, representing Biostatistics and Parexel, participating in business development, managing quality issues, and more. Requires Ph.D. or master's degree in statistical science with 6 years of relevant experience. Proficiency in SAS programming and knowledge of regulatory guidance and standards.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities
 Provide advise and expertise in statistical methods and techniques to internal Statisticians and
Programmers.
 Represent Biostatistics and Parexel.
 Participate in business development.
 Act as key contact regarding customer relationship management activities.
 Establish and maintain sound working relationships and effective communication with Clients
and global Early Phase biostatistical group.
 Organise and participate in Client and team meetings.
 Identify and facilitate training needs in collaboration with Line Managers.
 Manage quality issues.
 Monitor productivity.
 Participate in preparation of audits / inspections, audits and any follow up activities.
 Awareness of Revenue Recognition and associated tasks and timelines.
 Effectively communicate with internal and external customers as well as third party vendors.
 Prioritize effectively and respond to urgent requests within internal group and the Client.
Skills  Experience in all tasks of a Trial Statistician.  Proven knowledge in Statistics and its applications to clinical trials.  Proven knowledge of statistical software packages.  Good communication and presentation skills.  Possess strong negotiation, diplomacy, team leadership skills and excellent organizational ability.  Excellent interpersonal, verbal and written communication skills.  Ability to identify and address issues proactively in a timely manner.  Ability to make appropriate decisions in ambiguous situations.  Carefully weighs the priority of project tasks and directs team accordingly.  Excellent computer literacy.  Demonstrate a sound knowledge of all relevant regulations, including GCP.  Good team player. Education  A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 4 years relevant experience or a master’s degree plus 6 years relevant experience.  Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it to all phases of clinical trials.  Expertise in SAS programming including statistical analysis, data manipulation and scientific graphing.

 Demonstrated knowledge of all relevant statistical regulatory guidance and standards (e.g, FDA, ICH and EMA).

Top Skills

SAS
The Company
HQ: Durham, North Carolina
20,524 Employees
On-site Workplace

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.

Community Guidelines
Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:

• Abusive, harassing or threatening to others.
• Defamatory, offensive, obscene, vulgar or depicting violence.
• Hateful targeting by race/ethnicity, age, color, creed, religion, gender,
sexual preference or orientation, nationality or political beliefs.
• Sexually explicit or pornographic.
• Fraudulent, deceptive, libelous, misleading or unlawful.
• Referencing criminal or illegal activity.
• Spamming.

We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

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