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Principal Scientist, Statistical Programming Analysis & Reporting Standards- Hybrid
Principal Scientist, Statistical Programming Analysis & Reporting Standards- Hybrid-November 2024
North Wales
Nov 21, 2024
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About Principal Scientist, Statistical Programming Analysis & Reporting Standards- Hybrid

  Job Description

  Responsibilities:

  This position supports the strategic design, development, and delivery of efficient, flexible, and modular analysis and reporting and submission standards that can be used for drug and/or vaccine projects across all therapeutic areas. Adheres to standard operating procedures and guidelines established by the department. Drives data structures which include analysis and reporting data standards and submission standards. Actively leads and contributes to the department's strategic initiatives.

  The position is a key collaborator with internal and external stakeholders including Early and Late Stage Statistics, Statistical Programming, Data Management, Clinical Research, Regulatory, Observational Research, Clinical Safety, and PK/PD Modeling and Simulation organizations.

  Primary Activities:

  Address operational challenges that require strategic standard-based solutions, resulting in improved analysis and reporting deliverables.

  Facilitate global adoption of standards and programming best practices.

  Contribute to strategic solutions in support of cross functional stakeholder groups in BARDS, GCD, and our Research & Development Division.

  Provide technical consultation and analytical support to statistical programmers and statisticians.

  Lead and actively contribute to departmental strategic initiative project teams.

  Represent our company on relevant industry initiatives including CDISC and PHUSE

  Skills

  Education and Minimum Requirement :

  BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12-15 years SAS programming experience in a clinical trial environment.

  MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years SAS programming experience in a clinical trial environment and significant experience in developing global standards.

  Department Required Skills and Experience:

  Excellent interpersonal skills and ability to negotiate and collaborate effectively.

  Excellent written, oral, and presentation skills

  Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)

  Excellent project management skills; leadership across multiple and complex programs; 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 and familiarity with at least one other statistical computing software.

  Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) according to quality, compliance and timeliness requirements.

  Strong knowledge and understanding of CDISC SDTM and ADaM analysis dataset standards.

  Experience working with analytical research databases including various analysis datasets and procedures.

  Demonstrated understanding of statistics, clinical trial, and data management concepts as applied to drug/vaccine development.

  Demonstrated success in the assurance of deliverable quality and process compliance.

  Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions.

  Ability to anticipate stakeholder requirements.

  Ability and interest to work across cultures and geographies.

  **Preferred Skills and Experience:

  Experience leading implementation of Analysis & Reporting platform in a large organization

  Experience in developing flexible and efficient complex analysis and reporting standard SAS macros.

  Experience in process assessment, improvement and operational excellence methodologies

  Experience developing and managing a project plan using Microsoft Project or similar package.

  Active in R and or XML experience

  Experience with SAS in Unix

  Active in professional societies

  #EligibleforERP

  BARDS2020

  SPJOBS

  VETJOBS

  #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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

  Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

  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 (https://survey.sogosurvey.com/r/aCdfqL) 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, sex, sexual 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

  EEOC GINA Supplement​

  Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

  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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

  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:

  $164,800.00 - $259,400.00

  Available 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 (https://www.benefitsatmerck.com/) .

  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:

  No

  Travel Requirements:

  10%

  Flexible Work Arrangements:

  Hybrid

  Shift:

  Not Indicated

  Valid Driving License:

  No

  Hazardous Material(s):

  N/A

  Requisition ID: R276420

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