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manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and global PK/PD modeling and simulation stakeholders spanning all of our company's therapeutic areas except early oncology.
The Associate Principal Programmer will gather and interpret user requirements for analysis and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into analysis/modeling datasets, and develop
tables and figures according to statistical/modeling analysis plan. The position will partner with stakeholders to solve problems; reduce the amount of programming task being completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses.
The incumbent will write programs to analyze data with statistical methods which are not currently available through commercial software packages. The Associate Principal Programmer will be a key collaborator with statisticians, modelers, and colleagues in other related function areas. Primary Activities : Prepare compliant programming code for regulatory submissions including analysis/modeling datasets,
tables, listings, figures and associated documentation. Ensure programmatic traceability from data source to analysis/modeling result.
Maintain and manage a project plan including resource forecasting. Support the development of programming standards to enable efficient and high-quality production of programming deliverables. Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses. Represent statistical programming on process improvement activities. Education : BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 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 R&D 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 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 terminology and concepts; Implements statistical methods not currently available through commercial software packages.
Experience in CDISC SDTM and ADa M standards. Demonstrated success in the assurance of deliverable quality and process compliance. Thrives in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements, knowledge of medical development processes. Efficiently manipulates very large databases 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). Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.
Preferred Skills: Familiarity with clinical pharmacology concepts and pharmacokinetics concepts. Experience with at least one other software than SAS (e. g. R, Non Mem). 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. Experience providing technical and/or programming guidance and mentoring to colleagues. Background in process improvement. Active in professional societies. #Eligiblefor ERPBARDS2020SPJOBSVETJOBS#EBRG 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 separation package, 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. Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, interaction, interactionual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U. S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U. S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U. S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely.
Please note, this Hybrid work model guidance also does not apply to roles that have been designated as " remote"Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range: $130,960.00 - $206,200.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here. Search Firm Representatives Please Read Carefully Merck & Co. Inc. Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid, On-Site Shift: Valid Driving License: Yes Hazardous Material(s): Requisition ID: R261167PDN-9a46f093-331b-45dc-9586-59215a2a09a3
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