MSDMS

Senior Statistical Programmer, Late Stage Development, Oncology- Hybrid

We aspire to be the premier research-intensive biopharmaceutical company.

MSD

Employee count: 5000+

United States only

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

Responsibilities:

This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of 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.

The incumbant is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.

The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.

For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

Primary Activities:

  • Effective analysis and report programming development and validation utilizing global and TA standards and following departmental 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

  • Membership on departmental strategic initiative teams

Skills

Education and Minimum Requirement:

  • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment

  • MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment

Department Required Skills and Experience:

  • Effective interpersonal skills and ability to negotiate and collaborate effectively

  • Effective written, oral, and presentation skills

  • Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)

  • A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders

Position Specific Required Skills and Experience:

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

  • Designs and develops 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

  • Experience in CDISC and ADaM standards

  • Experience ensuring process compliance and deliverable quality

  • 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

  • Ability to anticipate stakeholder requirements

** Preferred Skills and Experience:

  • Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)

  • US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables

  • Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor

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

  • Active in professional societies

  • Experience in process improvement

eligibleforERP

Bards2020

SPjobs

VETJOB

EBRG

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, 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

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, Monday - 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”.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/2/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About the job

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Posted on

Job type

Full Time

Experience level

Senior

Location requirements

Hiring timezones

United States +/- 0 hours

About MSD

Learn more about MSD and their company culture.

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We aspire to be the premier research-intensive biopharmaceutical company. We’re at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Our purpose: We use the power of leading-edge science to save and improve lives around the world

For more than 130 years, we’ve brought hope to humanity through the development of important medicines and vaccines. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.

Our values

Our values represent the very core of our character. They guide every decision and action we take.

Patients first: We are all accountable for delivering high quality products and services. We aspire to improve the health and wellness of people and animals worldwide and to expand access to our medicines and vaccines. All of our actions must be measured against our responsibility to those who use or need our products.

Respect for people: Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, safety and teamwork of our employees. We work to create an environment of mutual respect, inclusion and accountability. We reward commitment and performance and are responsive to the needs of our employees and their families.

Ethics and integrity: We are committed to the highest standards of ethics and integrity. We are responsible to all of our stakeholders: employees, patients, customers, distributors and suppliers, shareholders, and the communities we serve worldwide. We do not take professional or ethical shortcuts.

Innovation and scientific excellence: We are dedicated to the highest standard of innovation and scientific excellence. Our research is guided by a commitment to improving health and quality of life. We strive to identify and meet the most critical needs of patients and customers through continuous innovation across all areas of our business.

Employee benefits

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Life insurance

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Healthcare benefits

Medical, dental, and vision insurance for employees.

Paid vacation

For employees outside the U.S., time off and leave benefits are based on local laws and market practices.

Disability insurance

Disability insurance to help protect our employees from the financial impact of unforeseen circumstances.

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MSD hiring Senior Statistical Programmer, Late Stage Development, Oncology- Hybrid • Remote (Work from Home) | Himalayas