Principal Biostatistician/ II- remote in the United States!

Submission for the position: Principal Biostatistician/ II- remote in the United States! - (Job Number: 171462)If you are an expert level lead statistician looking to continue growing your career as a project lead, and being the key contact for our clients, this is a wonderful opportunity for you!

What will you do in this role?

Oversees large scale projects to deliver the project statistician tasks/responsibilities.

Acts as the senior reviewer on simple or moderately complex projects, and with additional oversight as needed on complex or highly complex studies.

Performs project management function within the department.

Represents the department within the company and with interactions with client companies and regulatory agencies.

Able to act in the project oversight role on select projects.Essential Functions and Other Job Information:Provides expert knowledge and mentoring on statistical and regulatory issues, development/delivery of training, and implementation of best practices for the department.Serves as (or mentors/coordinates staff in the roles of) the lead statistician or project lead, overseeing multiple or large scale projects, ensuring adherence to company SOPs and working practices.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.May serve in a project oversight role for studies to represent the study(s) to all functions as needed, and fully accountable for all aspects of the management of risk.Interacts with sponsor counterparts or leadership, and/or other departments on status or topics related to the study(s) they are leading or overseeing.These topics can include but are not limited to timelines, quality, and cost subject matter.Provides technical input/writing into study design and statistical considerations during protocol development or review, SAP development/review, and provides expert knowledge and experience of complex trials design across different therapeutic areas.As assigned, oversees the preparation and review of key submission deliverables such as CSRs, ISS, ISE, Reviewers Guides, etc.Provides input and assistance to management for activities such as hiring recommendations, department policy development/review/training, process improvement initiatives, etc.Contributes to the identification and development of department documents or policies, input into SOP/WPD development and revision, developing of training material and/or overseeing the training new employees.Leads/accountable for bidding and business development activities for standalone opportunities and contributes significantly to full-service bids/proposals/budget revision and defense strategies. Prepares for and represents the company at bid defenses.

If you are an expert level lead statistician looking to continue growing your career as a project lead, and being the key contact for our clients, this is a wonderful opportunity for you!

What will you do in this role?

Oversees large scale projects to deliver the project statistician tasks/responsibilities.

Acts as the senior reviewer on simple or moderately complex projects, and with additional oversight as needed on complex or highly complex studies.

Performs project management function within the department.

Represents the department within the company and with interactions with client companies and regulatory agencies.

Able to act in the project oversight role on select projects.Essential Functions and Other Job Information:Provides expert knowledge and mentoring on statistical and regulatory issues, development/delivery of training, and implementation of best practices for the department.Serves as (or mentors/coordinates staff in the roles of) the lead statistician or project lead, overseeing multiple or large scale projects, ensuring adherence to company SOPs and working practices.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.May serve in a project oversight role for studies to represent the study(s) to all functions as needed, and fully accountable for all aspects of the management of risk.Interacts with sponsor counterparts or leadership, and/or other departments on status or topics related to the study(s) they are leading or overseeing.These topics can include but are not limited to timelines, quality, and cost subject matter.Provides technical input/writing into study design and statistical considerations during protocol development or review, SAP development/review, and provides expert knowledge and experience of complex trials design across different therapeutic areas.As assigned, oversees the preparation and review of key submission deliverables such as CSRs, ISS, ISE, Reviewers Guides, etc.Provides input and assistance to management for activities such as hiring recommendations, department policy development/review/training, process improvement initiatives, etc.Contributes to the identification and development of department documents or policies, input into SOP/WPD development and revision, developing of training material and/or overseeing the training new employees.Leads/accountable for bidding and business development activities for standalone opportunities and contributes significantly to full-service bids/proposals/budget revision and defense strategies. Prepares for and represents the company at bid defenses.

Education and Experience:Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 years’).Master degree in statistics, biostatistics, mathematics or related field with 7 years experienceExtensive 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:

• Mastery of the statistical principles underlying clinical trials

• Outstanding statistical skills

• Mastery of the regulatory issues associated with the reporting of clinical data in the submission process

• Excellent consultative skills

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

• Superb 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

• Excellent mentoring skills as shown by leadership of multiple projects and team members

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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).Education and Experience:Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 years’).Master degree in statistics, biostatistics, mathematics or related field with 7 years experienceExtensive 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:

• Mastery of the statistical principles underlying clinical trials

• Outstanding statistical skills

• Mastery of the regulatory issues associated with the reporting of clinical data in the submission process

• Excellent consultative skills

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

• Superb 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

• Excellent mentoring skills as shown by leadership of multiple projects and team members

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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).Submission for the position: Principal Biostatistician/ II- remote in the United States! - (Job Number: 171462)