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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

Primary Responsibilities:

• Develop and validate global programming standards and tools for the production of Study Data Tabulation Model (SDTM) datasets.

• Design and develop complex programming algorithms and user interfaces.

• Supporting project teams in creating SDTM deliverables for Analysis and Reporting activities and submission.

• Collaborating with project teams to prepare the Case Report Tabulation (CRT) submission deliverables including use of Pinnacle 21 Enterprise.

Education Minimum Requirements:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.

• MS (preferred) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.

Required Experience and Skills:

• Proven track record for leading a compound or indication.

• Out of the box thinker with experience in strategic initiatives, technology implementation, increasing programming efficiency, creating requirement documentation and understanding wider organizational objectives.

• Expertise in SAS for system development and clinical trial programming.

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

• Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), Define.XML, SDRG, aCRF; knowledge of Analysis Dataset Model (ADaM) and Analysis Data Reviewer’s Guide (ADRG) considered a plus.

• Excellent communication and interpersonal skills and ability to negotiate and partner effectively.

• Excellent written, oral, and presentation skills.

• Excels in technical writing, able to convert complex ideas and information into simple readable form.

• Strong project management skills; Manage at a program level; influences approach/s and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.

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

• Familiarity with statistics and clinical data management concepts.

​​

Preferred Experience and Skills:

• Strong working knowledge of reporting processes Standard Operating Procedures (SOPs) and software development life-cycle (SDLC).

• Provide technical and/or programming guidance and mentoring to colleagues.

• Deals well with change and seamlessly assimilates to new projects and stakeholders.

• Ability to anticipate stakeholder requirements.

• Strategic thinking ability to turn strategy into tactical activities.

• Ability and interest to work across cultures and geographies.

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

• Develop and manage project plan using Microsoft Project or similar package.

• Active in industry forums and professional societies.

• Process improvement and familiarity with Meta Data Repositories.

• United States and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of CRT SDTM study data standard deliverables.

• Strong knowledge of study data standards.

• Up-versioning activities to specific versions of Statistical Analysis System (SDTM).

• Participation in industry teams and conferences on best practices.

• Membership on departmental strategic initiative project teams.

Keyword: SASPRO

BARDS2020

SPjobs

EBRG

eligibleforERP

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.

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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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$135,500.00 - $213,400.00

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

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

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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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

Job Posting End Date:

11/21/2024

*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.

Requisition ID: R314000