As a Senior Programmer Analyst within Early Development Services (EDS), you will perform advanced bioinformatics programming activities for the statistical and computational considerations of research projects.

Essential Functions:

• Acts as the lead programmer on selected studies of moderate complexity, working directly with project team leaders and client representatives to assess and develop project goals and timelines. Assumes leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team, communicating actively and frequently with other team members as needed.
• 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 and guidance 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 support to the bidding process as requested.

Education and Experience:

• MS/MA degree in computer science, statistics, biostatistics, mathematics or related field and at least 3 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 and relevant formal academic / vocational qualification, and at least 5 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.

Knowledge, Skills and Abilities:

• Solid understanding of one or more programming languages. SAS experience essential.
• Solid attention to detail
• Comprehensive problem solving and innovative skills
• Solid 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
• Strong understanding of relational data base structure and complex data systems
• Capable of training and mentoring others
• Capable of effectively capturing biostatistical metrics
• Capable of providing quality control review for statistical programming

As a Principal Biostatistician (FSP) you will work directly with the client as part of their team. Executing diverse statistical tasks supporting the clinical development programs within the client setting. The tasks mainly focus on managing the statistical activities performed by the biostatistics CRO and on guaranteeing by means of thorough review outstanding statistical quality. Will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing all study outputs and the CSR.

Education and Experience:

• Master degree in statistics, biostatistics, mathematics or related field with 7+ years experience
• Extensive experience of statistics in a clinical trial environment.
• Extensive project lead/PM experience, clearly demonstrated in previous positions
• Evidence of providing expert statistical input in previous positions

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
• 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

Summarized Purpose:

Performs a statistical consulting role both internally and externally. Serves as the lead statistician on broad-based projects or complex, multiple protocol programs as required. Serves as the scientific and therapeutic area thought leader for study design and statistical analysis issues. Provides scientific strategy consultation to clients for drug or device development planning. Provides statistical input into corporate initiatives. Maintains expertise in state-of-the-art data manipulations and statistical analyses. Represents the department to clients on complex study scientific and design considerations, directly contributing to complex study proposals and bids, representing the department at bid defenses.

Essential Functions:

• Provides expert knowledge within the department on statistical and regulatory issues, mentoring members of the department and providing project guidance and statistical advice.
• Serves as a lead statistician on high complexity statistical projects and for consulting projects.
• Provides expert knowledge and experience to project teams on complex and novel statistical methodology across different therapeutic areas.
• Provides statistical support to global corporate initiatives and supports/leads departmental efforts on working groups.
• Provides expertise and leads the development and delivery of technical training for the department and the company.
• Provides input into study design and sample size calculations during protocol development, writes or reviews statistical analysis plans and performs or validates statistical analyses.
• Provides senior review on projects.
• Provides input to management as to hiring recommendations, department policies, and resourcing requirements.
• Assists in bidding, proposal development and other business development activities, as required.

Education and Experience:

• Master's degree in statistics, biostatistics, or equivalent field with appropriate statistical coursework and 5+ years of clinical trial experience as a statistician;
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years').

OR

• PhD. in statistics, biostatistics, or equivalent field with appropriate statistical coursework and 3+ years of clinical trial experience as a statistician. 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:

• Demonstrated initiative and motivation
• Excellent verbal and written communication skills, including proficiency in the English language
• Positive attitude and the ability to work well with others in a multi-disciplinary setting
• Excellent understanding of SAS® and clinical biostatistics
• Demonstrated understanding of the drug development process
• Conversant knowledge of FDA and other regulatory guidances and regulations
• Capable of managing change and uncertainty to optimize positive outcomes
• Excellent project management skills, including leadership of complex projects
• Excellent organizational skills with the ability to adapt and adjust to changing priorities
• Strong theoretical background and applied statistical knowledge
• Capable of mentoring with regard to scientific principles, statistical methodology, and/or knowledge of a specific therapeutic are
• Capable of communicating complex statistical concepts in a multi-disciplinary setting
• Demonstrated knowledge in one or more therapeutic areas