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Sr 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 the SR Biostatistician role?  Below is more information.

Summarized Purpose:   

Functions independently as a project lead or lead statistician to deliver the project tasks/responsibilities. Performs project management functions relating to the administrative and scientific activities of specific project work and team members. Oversees statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians.  Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.  

Essential Functions:    

Ensures compliance with the activities outlined in the department's Working Practice Documents and contributes changes as needed. Follows departmental procedures for statistical analyses and programming work.  

Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across large and complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed. 

Provides sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Provides randomization schemes and appropriate documentation.  

Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis.  

Provides specifications for analysis database, oversee its development, and assures completeness for use in all programming. Coordinates with programmers and data management personnel as to database maintenance, updating, and documentation. Performs statistical analysis for key efficacy endpoints.  

Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.  

Monitors project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management.  

Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning. 

Provides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires).  

Consults with business development with respect to bids and timelines.  

Education and Experience:   

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’).  Master's degree in statistics, biostatistics, mathematics or related field. 

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:   

Strong SAS® programming skills  

(Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures  

Capable of directing and promoting teamwork in a multi-disciplinary team setting  

Strong understanding of statistical principles and strong statistical skills  

Solid project management skills, as shown through management of multiple projects 

Demonstrated initiative and motivation  

Strong written and verbal communications skills, including proficiency in the English language  

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

Strong interpersonal skills and positive attitude to work effectively in a team environment and act as a liaison with other department  

Project Lead experience in industry, along with using CDISC

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 $108,000-130,000. 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: 2022-12-19

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