Job Description

This position leads statistical programming activities for multiple and/or late-stage drug/vaccine clinicaldevelopment projects. Accountability predominantly includes the development and execution of statisticalanalysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span ofwhich range from individual clinical trials to world-wide regulatory application submissions and post marketingsupport.

The incumbent is responsible for the design and maintenance of statistical datasets that support multiplestakeholder 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 areexecuted efficiently with timely and high-quality deliverables.

For assigned projects the position serves as the statistical programming point of contact and knowledge holderthrough 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

Education and Minimum Requirement:

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

• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 7 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 R26D projects(data, analyses, tables, graphics, listings)

• Strong project management skills; leadership at a program level; determines approach and ensuresconsistency 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; systems and database expertise

• Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team

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

• Designs and develops complex programming algorithms

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

• Familiarity with clinical data management concepts

• Experience in CDISC and ADaM standards

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

• Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end inmind that optimize analysis and reporting and leverage departmental standards and industry best-practices

• Ability to anticipate stakeholder requirements

** Preferred Skills and Experience:

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

• Experience with GenAI tools (e.g., Python, R, R Shiny, Claude, etc.)

• Experience providing technical and/or programming guidance and mentoring to colleagues

• 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

BARDS2020

eligibleforERP

SPjobs

VETJOBS

EBRG

Required Skills:

Preferred Skills:

Current Employees apply

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employeeposition within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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 Angeles99 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.

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