Principal Programmer - Customer Dedicated (FSP) Contract Opportunity

Submission for the position: Principal Programmer - Customer Dedicated (FSP) Contract Opportunity - (Job Number: 186969)

Who is PPD?

PPD is a leading global contract research organization.Ourpurposeis to improve health. Ourmissionis to help customers deliver life-changing therapies. Ourstrategyis to bend the cost and time curve of drug development and optimize value for our customers.

The PPD FSP Solution

PPD's Functional Service Provider division partner with andserve as an extension of our PPD team, supporting our customers key functions.We cover customer needson every level, allowing them to do more with less, with an uncompromising commitment to quality.Wedeploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Responsibilities:

Acts as the lead programmer, project lead, or project oversight lead on multiple projects, overseeing the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting. Organizes teams and implements study strategies to ensure process and programming efficiencies, and the creation and maintenance of programs for statistical report generation, and program validation. Represents the department within the company and with interactions with client companies and regulatory agencies. Provides training, guidance, and project leadership to junior team members. Serves as a lead programmer or project lead on studies or drug programs of all complexities and size scales. Works directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and ensure adherence to study budgets and any relevant contractual obligations or limits with clients. Suggests, plans and provides developments to tools and techniques for improving process efficiencies. Actively contributes to process or tool improvement efforts including leadership of solution teams. Represents the department to clients on study matters, bid defenses or submission or review of clinical data to regulatory authorities, directly contributing to proposals and bids. May serve as company project manager on projects limited to only biometrics services. Performs critical review of derived datasets specifications and derived datasets (ADaM). Develops programs to perform QC of statistical outputs. Defines program specific standards for ADaM datasets. Checks compliance of CRO delivered ADaM datasets to CDISC standards. Verifies define.xml (for ADaM’s) and ADRG. Develops, validates and documents programs for additional post-hoc analyses. Develops, reviews, documents and performs validation of generic SAS macros, and creates a macro library. Supports data submission activities according to regulatory guidelines (e.g. ISS, ISE). Supports outsourcing programming activities and oversees the QC of these activities. Can assess well time needed for all programming related activities.

Who is PPD?

PPD is a leading global contract research organization.Ourpurposeis to improve health. Ourmissionis to help customers deliver life-changing therapies. Ourstrategyis to bend the cost and time curve of drug development and optimize value for our customers.

The PPD FSP Solution

PPD's Functional Service Provider division partner with andserve as an extension of our PPD team, supporting our customers key functions.We cover customer needson every level, allowing them to do more with less, with an uncompromising commitment to quality.Wedeploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Responsibilities:

Acts as the lead programmer, project lead, or project oversight lead on multiple projects, overseeing the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting. Organizes teams and implements study strategies to ensure process and programming efficiencies, and the creation and maintenance of programs for statistical report generation, and program validation. Represents the department within the company and with interactions with client companies and regulatory agencies. Provides training, guidance, and project leadership to junior team members. Serves as a lead programmer or project lead on studies or drug programs of all complexities and size scales. Works directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and ensure adherence to study budgets and any relevant contractual obligations or limits with clients. Suggests, plans and provides developments to tools and techniques for improving process efficiencies. Actively contributes to process or tool improvement efforts including leadership of solution teams. Represents the department to clients on study matters, bid defenses or submission or review of clinical data to regulatory authorities, directly contributing to proposals and bids. May serve as company project manager on projects limited to only biometrics services. Performs critical review of derived datasets specifications and derived datasets (ADaM). Develops programs to perform QC of statistical outputs. Defines program specific standards for ADaM datasets. Checks compliance of CRO delivered ADaM datasets to CDISC standards. Verifies define.xml (for ADaM’s) and ADRG. Develops, validates and documents programs for additional post-hoc analyses. Develops, reviews, documents and performs validation of generic SAS macros, and creates a macro library. Supports data submission activities according to regulatory guidelines (e.g. ISS, ISE). Supports outsourcing programming activities and oversees the QC of these activities. Can assess well time needed for all programming related activities.

Qualifications:

Education and Experience

MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 6years of experience that provides the knowledge, skills, and abilities to perform the job requirements, or Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and at least 8 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.

Knowledge, Skills and Abilities: Strong SAS® programming skills Thorough knowledge of CDISC standards Great understanding of database structures and working with complex data structures Demonstrated great attention to detail Excellent problem solving and innovative skills Excellent written and verbal communication skills to facilitate communications with clients, project teams, departments and staff, including proficiency in the English language Capable of independently organizing, adapting and adjusting to changing priorities across multiple assignments Capable of working and leading in a multidisciplinary team setting Demonstrated positive attitude and the ability to work well with others Capable of coaching and mentoring others, as shown by leadership of projects Good understanding clinical trials, ICH Statistical and reporting guidelines and GCP Excellent knowledge of statistical principles applied to the design and analysis of clinical trials Good understanding of the requirements involved in the submission of clinical data to regulatory authorities Excellent project management skills, such as project budget creation, including modifying for project updates, and managing project budgets and risks

Work Environment Requirements:

PPD values the health and wellbeing 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 and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

PPD® FSP: People Who Deliver | PPD Careers- Read about PPD employee experiences! Qualifications:

Education and Experience

MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 6years of experience that provides the knowledge, skills, and abilities to perform the job requirements, or Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and at least 8 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.

Knowledge, Skills and Abilities: Strong SAS® programming skills Thorough knowledge of CDISC standards Great understanding of database structures and working with complex data structures Demonstrated great attention to detail Excellent problem solving and innovative skills Excellent written and verbal communication skills to facilitate communications with clients, project teams, departments and staff, including proficiency in the English language Capable of independently organizing, adapting and adjusting to changing priorities across multiple assignments Capable of working and leading in a multidisciplinary team setting Demonstrated positive attitude and the ability to work well with others Capable of coaching and mentoring others, as shown by leadership of projects Good understanding clinical trials, ICH Statistical and reporting guidelines and GCP Excellent knowledge of statistical principles applied to the design and analysis of clinical trials Good understanding of the requirements involved in the submission of clinical data to regulatory authorities Excellent project management skills, such as project budget creation, including modifying for project updates, and managing project budgets and risks

Work Environment Requirements:

PPD values the health and wellbeing 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 and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

PPD® FSP: People Who Deliver | PPD Careers- Read about PPD employee experiences! Submission for the position: Principal Programmer - Customer Dedicated (FSP) Contract Opportunity - (Job Number: 186969)