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Senior Scientist, Statistical Programming
Senior Scientist, Statistical Programming-November 2024
North Wales
Nov 24, 2024
ABOUT MERCK
Merck enables a safe, sustainable and healthy future for people and communities everywhere...
10,000+employees
Healthcare
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About Senior Scientist, Statistical Programming

  Job Description

  Responsibilities:

  Provide support to statistical programming activities for late stage drug clinical development projects.

  Develop and execute statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.

  Design and maintain statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.

  Act as key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables.

  Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle for assigned projects.

  Perform effective analysis and report programming development and validation utilizing global and Therapeutic Area standards and following departmental standard operating procedures (SOPs) and good programming practices.

  Maintain and manage a project plan including resource forecasting.

  Coordinate the activities of a global programming team that includes outsource provider staff.

  Serve as a member on the departmental strategic initiative teams.

  Education Requirements:

  Must have a Bachelor’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least five (5) years SAS programming experience in a clinical trial environment or a Master’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least three (3) years SAS programming experience in a clinical trial environment.Required experience and skills:

  Must have experience in CDISC and ADaM standards and ability to ensure process compliance and deliverable quality.

  Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; and systems and database expertise also required.

  Applicant must also possess effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings);

  Effective interpersonal skills and ability to negotiate and collaborate effectively;

  Effective written, oral, and presentation skills; the ability to design and develop complex programming algorithms;

  Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts;

  Familiarity with clinical data management concepts; and ability to anticipate stakeholder requirements.

  Must be project leader with ability to complete tasks independently at a project level and ability to collaborate with key stakeholders.

  Ability to think strategically, specifically ability to turn strategy into tactical activities; and design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices also required.

  Telecommuting permitted.

  40 hours per week: M-F: 9am-5pm.

  Must have proof of legal authority to work in the United States.

  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”.

  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:

  No relocation

  VISA Sponsorship:

  No

  Travel Requirements:

  No Travel Required

  Flexible Work Arrangements:

  Telecommuting

  Shift:

  1st - Day

  Valid Driving License:

  No

  Hazardous Material(s):

  No

  Requisition ID: R272080

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