Primary Activities
PreNDA and PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA).
Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise.
Up-versioning activities to specific versions of SDTM.
Participation in industry teams and conferences on best practices.
Membership on departmental strategic initiative project teams.
Education and Minimum Requirement
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment.
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 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 stakeholder.
Position Specific Required Skills and Experience
US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG.
Demonstrated success in the assurance of deliverable quality and process compliance.
Excels in technical writing, able to convert complex ideas and information into simple readable form.
Solid project management skills.
Familiarity with clinical data management concepts.
Strategic thinking - ability to turn strategy into tactical activities.
Ability to anticipate stakeholder requirements.
Preferred Skills and Experience
Hands-on experience with R and Python for data analysis and statistical modeling.
Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC).
Experience assuring consistency across protocols and projects.
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
SPjobs
BARDS2020
VETJOBS
EBRG
Required Skills
Clinical Data Interchange Standards Consortium (CDISC) Standards, Data Management, Data Modeling, Numerical Analysis, Stakeholder Relationship Management, Study Data Tabulation Model (SDTM), Waterfall Model
Preferred Skills
Python (Programming Language), R Programming
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.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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
The primary location for this posting is
USA - Pennsylvania - Upper Gwynedd
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is
$117,000.00 - $184,200.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position 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 https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
Additional location(s) Compensation Information
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
Domestic
VISA Sponsorship
No
Travel Requirements
10%
Flexible Work Arrangements
Hybrid
Shift
Not Indicated
Valid Driving License
No
Hazardous Material(s)
n/a
Job Posting End Date
- 11/30/2026
- 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.
