Biostatistician II (remote or office)

Pharmaceutical Product Development, Inc.

Wilmington North Carolina

United States

Scientific Research
(No Timezone Provided)

PPD's mission is to improve health.It starts as an idea to cure. It becomes a life saved. All in-between, it's you!We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside bright and energetic teams. What is this role responsible for?Functions independently as a lead statistician with minimal oversight to deliver the project statistician tasks/responsibilities, including analysis database creation, statisticial analyses, and creation of formatted statistical analysis tables and summaries. Provides mentorship to junior team members. Essential Functions:Ensure compliance with the activities outlined in the department's SOPs. Follows departmental procedures for statistical analyses and programming work. Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Ensures that SOPs are being followed and that appropriate project documentation is ongoing. Interacts with the sponsor on all aspects of the project. Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis. Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Provides randomization schemes and appropriate documention. Deveops statistical analysis plan, including analysis database and table listing specifications, and guide others on the team in its implementation. Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversee the work of others who assist in programming/validating. Reviews reports and other documents and manuscripts. Contributes to the statistical methods section and verify for completeness and consistency for report. Monitors project budget as it relates to project work scope and commuicates proactively with management concerning potential changes in work scope. Provides general infrastructure support to the department. Examples could include presentation/teaching at department, contributing to other general department documents or polices, assisting with newletters, helping in department libraries, or training of new hires. Qualifications:Education and Experience:Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years'). Master's degree in statistics, biostatistics, mathematics or related field.In somecasesan 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: Solid SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures Capable of providing mentorship and promoting teamwork in a multi-disciplinary team setting Solid understanding of statistical principles and good statistical skills Capable of creating study specifications and providing support in the review of data management documentation Good project management skills as shown through management of multiple projects Solid written and verbal communications skills, including proficiency in the English language Good organizational skills with the ability to adapt and adjust to changing priorities Positive attitude and the ability to work well with others 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).*LI-KF1*LI-remote

Biostatistician II (remote or office)

Pharmaceutical Product Development, Inc.

Wilmington North Carolina

United States

Scientific Research

(No Timezone Provided)

PPD's mission is to improve health.It starts as an idea to cure. It becomes a life saved. All in-between, it's you!We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside bright and energetic teams. What is this role responsible for?Functions independently as a lead statistician with minimal oversight to deliver the project statistician tasks/responsibilities, including analysis database creation, statisticial analyses, and creation of formatted statistical analysis tables and summaries. Provides mentorship to junior team members. Essential Functions:Ensure compliance with the activities outlined in the department's SOPs. Follows departmental procedures for statistical analyses and programming work. Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Ensures that SOPs are being followed and that appropriate project documentation is ongoing. Interacts with the sponsor on all aspects of the project. Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis. Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Provides randomization schemes and appropriate documention. Deveops statistical analysis plan, including analysis database and table listing specifications, and guide others on the team in its implementation. Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversee the work of others who assist in programming/validating. Reviews reports and other documents and manuscripts. Contributes to the statistical methods section and verify for completeness and consistency for report. Monitors project budget as it relates to project work scope and commuicates proactively with management concerning potential changes in work scope. Provides general infrastructure support to the department. Examples could include presentation/teaching at department, contributing to other general department documents or polices, assisting with newletters, helping in department libraries, or training of new hires. Qualifications:Education and Experience:Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years'). Master's degree in statistics, biostatistics, mathematics or related field.In somecasesan 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: Solid SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures Capable of providing mentorship and promoting teamwork in a multi-disciplinary team setting Solid understanding of statistical principles and good statistical skills Capable of creating study specifications and providing support in the review of data management documentation Good project management skills as shown through management of multiple projects Solid written and verbal communications skills, including proficiency in the English language Good organizational skills with the ability to adapt and adjust to changing priorities Positive attitude and the ability to work well with others 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).*LI-KF1*LI-remote