Jobs at Pharmaceutical Product Development (PPD)

Our Biostatistics & Programming (B&P) department are passionate about being data and technically agile and driving enhanced value for our clients and patients. Determined to improve patient health, we help the business provide industry leading CDISC expertise and programming leadership through global delivery, consistent quality adherence and scientific insight.

Your responsibilities will include (but are not limited to) the following:

• Creation of specifications, development, validation, and delivery of CDISC SDTM and regulatory deliverables (eCRT Define.xml, SDTM aCRF).
• Analysing and combining data from a variety of sources and structures including virtual trials, wearables, eCOA, etc.
• Generating visualizations (Spotfire), Statistical safety reports (TLFs), safety event notifications and data alerts for study teams.
• Provide consult, analysis, and support across various therapeutic area studies in their CDISC compliance and consistency in mapping.
• Act as programming lead on Phase II-IV studies of moderate to high complexity.
• As programming lead working directly with project team leaders and client representatives and where required to conduct team meetings, develop, and maintain project timelines, assess, and forecast resources, and monitor study budgets.
• Develop instructional training and education materials for the wider B&P community.
• Provide mentorship to junior team members.

Job Qualification

Education, Experience and Skills required:

• MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and 4-5+ years of experience.
• In-depth understanding of SAS and, ideally, one other programming language.
• In-depth understanding of relational data base structure and complex data systems.
• Capable of effectively capturing biostatistical metrics.
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.
• Capable of independently and effectively organizing and managing multiple assignments with challenging timelines.
• Solid project management skills to act as project lead across the most challenging and complex projects.
• Demonstrated leadership, initiative, and motivation.
• Capable of training and mentoring others.
• Fluent in English.

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Responsibilities:

• Join the Bios Infrastructure, Tools and Standards (BITS) team, and collaborate with other BITS members on process improvement initiatives.
• Develop tools and processes that will streamline Biostatistics and Programming deliveries.
• Assess current tools and processes to determine where they can be improved and extended.
• Collaborate with project teams to show them how to optimize their use of BITS tools.
• This role is 100% non-billable and is therefore ideal for experienced SAS programmers who want to move away from project work, and yet remain in Biostatistics.

Job Qualification

• MS/MA degree in computer science, statistics, biostatistics, mathematics, or related field and at least 6 years of experience that provides the knowledge, skills, and abilities to perform the job requirements
• 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:

• SAS programming experience within clinical research trials is required. Successful candidates must be familiar with Statistical Analysis Plans (SAPs), SDTM datasets, ADaM datasets, and statistical tables, listings, and figures (TLFs).
• VBA and .NET experience is desirable, but not required
• Ability to provide mentorship and promote teamwork in a multi-disciplinary team setting
• Strong knowledge of statistical principles and strong statistical skills
• Ability to create design specifications and validation plans for new applications or features
• Proven performance of required tasks, as evidenced in outstanding performance in current tasks and/or documented record of accomplishments
• Evidence of strong management skills, as shown through management of multiple projects and/or staff members
• Excellent written and verbal communications skills
• Good organizational skills with the ability to adapt and adjust to changing priorities
• Positive attitude and the ability to work well with others

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As a Principal Programmer, you will act as the lead programmer, project lead, or project oversight lead on multiple projects for various clients, overseeing the statistical and bioinformatics programming aspects of clinical trials from design through analysis and reporting. 

Your responsibilities will include (but are not limited to) the following:

• Acts as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.  
• Assumes leadership responsibility as a contributing member of a multidisciplinary project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.  
• Independently creates, executes, maintains, and validates programs that transfer data across multiple data management systems or operating systems, combines data from a variety of sources and structures, generates and stores summary data from a variety of sources, generates reports or combines multiple databases and validates programs that generate listings, tables and figures using SAS.  
• Manages and documents assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.  
• Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.  
• Provides training, guidance, and project leadership to junior team members.  
• Provides general infrastructure support to the Department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials, and contributing to other general department documents or policies such as the development of departmental working practice documents and SOPs.  
• Provides input into bidding process as requested.

Job Qualification

Education and Experience: 

• MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 4 years 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 formal academic / vocational qualification, and at least 6 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.  

Knowledge, Skills and Abilities: 

• In-depth understanding of one or more programming languages  
• Strong attention to detail  
• Strong problem solving and innovative skills  
• Strong written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language  
• Capable of independently and effectively organizing and managing multiple assignments with challenging timelines  
• Capable of adapting and adjusting to changing priorities  
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others  
• Demonstrated leadership, initiative and motivation  
• In-depth understanding of relational data base structure and complex data systems  
• Capable of training and mentoring others  
• Demonstrated leadership ability and ability to work on a multi-disciplinary project team  
• Solid project management skills to act as project lead across the most challenging and complex projects  
• Capable of effectively capturing biostatistical metrics  
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.

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Our Biostatistics department are passionate about being data and technically agile, and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight. 

We are currently recruiting for an Early Development Services (EDS) Senior Biostatistician to join the team based in EMEA.  As a Sr Biostatisitician you will;

• Develop statistical analysis plans, including tables & listing specifications 
• Provide randomization schemes and appropriate documentation 
• Provide sample size calculations and review protocols for completeness, appropriateness of clinical design and sound statistical analysis  
• Coordinate and collaborate with Programmers and Data Management personnel as to database maintenance, updating and documentation.  
• Lead the project team, conduct team meetings, maintain project timelines and monitor project budget, assess and allocate resources as required. 
• Provide mentorship to junior team members