Job Abstract

Job Description

Responsibilities:

This position provides high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders spanning all our company's therapeutic areas.  The programming analyst will gather and interpret user requirements, retrieve the required data, transform the data into modeling-ready analysis datasets, and develop tables and figures according to the modeling analysis plans.   The programming analyst will take on a data stewardship leadership role and be accountable for the creation of modeling data from original data source(s) to final modeling dataset.  The programming analyst will be a key collaborator with modelers, statisticians and other project stakeholders and is expected to execute project plans efficiently and oversee the work of other team members when opportunities arise.

Primary Activities:

• Programmatically synthesize preclinical / clinical data into analysis ready structures from varied data sources

• Create modeling-ready datasets by integrating PK, ADA, PD and covariate data

• Produce tables, listings and graphics for inclusion in study reports and regulatory submissions

• Ensure programmatic traceability from data source to modeling result

• Support the development of programming standards to enable efficient and high quality production of programming deliverables

• produce SAS transport files and associated documentation for regulatory submissions

• Represent statistical programming on process improvement activities

Education and Minimum Requirement:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 years SAS programming experience in a clinical trial environment

• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment

Department Required Skills and Experience:

• Excellent interpersonal skills and ability to negotiate and collaborate effectively

• Excellent written, oral, and presentation skills

• Broad knowledge and significant experience in developing analysis and reporting deliverables for Research &Development projects (data, analyses, tables, graphics, listings)

• Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders

Position Specific Required Skills and Experience:

• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH

• Designs and develops complex programming algorithms

• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical or pharmacokinetic terminology and concepts; Implements statistical methods not currently available through commercial software packages.

• Demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes

• Efficiently manipulates clinical trial datasets including complex data preprocessing, filtering, and manipulation; programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters)

** Preferred Skills and Experience:

• Familiarity with pharmacokinetics modeling and simulation datasets and analyses

• Experience with at least one other software than SAS (e.g., R, Splus, NonMem)

• Good working knowledge of reporting processes (SOPS) and software development life cycle (SDLC)

• Utilizes and contributes to the development of standard departmental SAS macros

• Ability and interest to work across cultures and geographies

• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff

• Active in professional societies

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Expected salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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