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Principal Biostatistician (remote)

Pharmaceutical Product Development (PPD)

Multiple locations

Are you ready for an amazing opportunity that truly will make a difference, with an amazing team and incredible leadership?  If so, you are in the right place!  

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.    

 What will you be doing in this role?  Please check out more details below.

Summarized Purpose:   

Serves as a subject matter expert and lead in providing statistical, process and regulatory knowledge to the department. Acts as the senior reviewer on simple or moderately complex projects, and with additional oversight as needed on complex or highly complex studies. Acts as a project manager, overseeing the statistical and programming aspects of clinical trials from design, through analysis and reporting, acting as the lead statistician on multiple projects. Represents the department within the company and with interactions with client companies and regulatory agencies, on simple to complex study design matters, directly contributing to complex study proposals and bids, representing the department at bid defenses. Organizes teams and implements strategies to ensure process and programming efficiencies on complex studies. 

Essential Functions:     

Provides expert knowledge within the department on statistical and regulatory issues, mentors members of the department and provides project guidance and statistical advice. Provides expert knowledge and experience of complex trials design across different therapeutic areas.  

Provides expertise in the development and delivery of training material, and the implementation of departmental procedures for the team. Contributes to process improvement and departmental initiatives.  

Serves as senior reviewer on simple or moderately complex studies as assigned with minimal oversight, and on more complex studies as assigned with supervision as needed.  

Serves as a lead statistician on multiple projects and leads project teams for multiple protocols. Conducts team meetings, maintains project timelines, assesses resource need, provides resources, and budget management. Ensures that SOPs are being followed and that appropriate project documentation is ongoing. Provides management with timely, accurate status and resourcing reports. Allocates and coordinates resources within the team to achieve timelines, time management of own and team's time spent on projects.  

Interacts with the sponsor on statistical aspects of the project and present at meetings as required.  

Produces sample size calculations. Provides input into study design and statistical considerations, during protocol development. Review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate protocol sections.  

Leads the development and review of statistical analysis plans, including table, listing and graph specifications. Organizes the production of statistical analyses and statistical appendices, with appropriate documentation. Ensures that appropriate validation for statistical analyses and statistical appendices is implemented.  

Specifies the general structure of the analysis database, oversees its development, and ensures completeness for use in all programming. 

Oversees the preparation and quality review of statistical reports, integrated summaries of safety, integrated summaries of efficacy and other documents, as required. Contributes statistical methods section for integrated clinical statistical reports.  

Provides input to management as to hiring recommendations, department policies, and resourcing requirements.

Assists in bidding and business development activities, as required.  

Education and Experience:    

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years’).  Master's degree in statistics, biostatistics, mathematics or related field  

Extensive experience of statistics in a clinical trial environment. Evidence of providing expert statistical input in previous positions and presenting at statistical conferences would be an advantage. 

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.  

Knowledge, Skills and Abilities:   

Excellent understanding of the statistical principles underlying clinical trials  

Excellent statistical skills  

Excellent understanding of the regulatory issues associated with the reporting of clinical data in the submission process  

Great consultative skills  

Outstanding SAS® programming skills and familiarity of other statistical packages (eg StatXact, Nquery) and understanding of database structures  

Excellent organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects  

Capable of adapting and adjusting to changing priorities 

Excellent written and verbal communication skills, including proficiency in the English language  

Capable of working in a multi-disciplinary team setting  

Demonstrated initiative, motivation and problem-solving skills  

Positive attitude and the ability to organise a team and work well with others  

Strong project lead experience working with clinical trial studies

EEOC:  We are an inclusive equal employment opportunity company.  We value all people regardless of background, experience and abilities.  Below is listed the working environment/requirements for this role:Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary for typical working hours.Ability to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.May require travel.  (Recruiter will provide more details).

The salary range estimated for this position is $150,000-165,000. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:

  • A choice of national medical and dental plans, and a national vision plan
  • A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Account (HRA) or Health Savings Account (HSA)
  • Tax-advantaged savings and spending accounts and commuter benefits
  • Employee assistance program
  • Paid Time Off, 10 paid holidays annually, 8 hours of volunteer time, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

 If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

#PPDHP

Job posted: 2023-02-08

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