New · posted Nov 1
Merck · Pharmaceuticals
Principal Scientist, Biostatistics, Late-Stage Clinical Development
- North Wales, PA
- Hybrid
- Full-time
- Senior & Principal
The role
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 activities
- Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
- Is involved in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
- Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out.
- Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
- Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.
- May lead a team of statisticians and statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements
- Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.
- Analyzes data and interprets results from clinical trials to meet objectives of the study protocol. Independently applies and implements basic and complex statistical techniques to these analyses.
- Prepares oral and written reports to effectively communicate results of clinical trials to the project team, our company's Management, regulatory agencies, or individual investigators.
- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
- May represent biostatistics in regulatory interactions including presentation at advisory committee meetings
- Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.
- Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
- Involved in research activities for innovative statistical methods and applications in clinical trial development.
- Mentors and guides junior staff in functional activities.
What you need
Education and Minimum Requirement
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or a Master’s degree with a minimum of 9 years relevant work experience.
Required Skills and Experience
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong project management skills.
- Solid knowledge of statistical and data processing software e.g. SAS and/or R.
- Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.
- Strong oral and written communication skills. Able to function effectively in a team environment.
- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
Required Skills
Clinical Trials, Data Management, Data Science, Scientific Modeling, Statistical Analysis, Study Design
Travel Requirements
10%
Valid Driving License
No
Preferred Skills and Experiencenice to have
- Publications in peer reviewed statistical/medical journals.
- An understanding of biology of disease and drug discovery and development.
BARDS2020
What you'll do
- Serves as a statistical lead in project teams.
- Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.
- Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and our company Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.
- May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
- The incumbent may initially work in a specific disease area such as oncology.
Pay and benefits
$191,000 – $300,000 a year
Employer providedAdditional 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
Medical, dental and vision insurance
Retirement benefits including 401(k)
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
North Wales, PAHybridOpen in Maps (opens in a new tab)
More jobs in North Wales, PAWorking conditions
Not Indicated
Hazardous Material(s)
n/a
Employee Status
Regular
Relocation
Domestic
VISA Sponsorship
Yes
Flexible Work Arrangements
Hybrid
Job Posting End Date
11/24/2026
*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.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
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:
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 - North Wales (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:
$190,800.00 - $300,300.00
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.
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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 32% above the US median for Clinical Development roles at this level.
This roleEmployer provided
Senior & Principal roles in the US11 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $191,000 | — | $300,000 |
| All US (middle half) | $177,250 | $186,500 | $300,500 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Clinical Development roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Development
The general path across 263 open Clinical Development roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct13
- Collaboration and leadership9
- Lab testing and methods7
- Data and digital systems4
- Investigations and CAPA3
- Documentation and SOPs2
Company hiring pulse
Merck on Regulatory Jobs
- 25
- Open roles
- 25
- Distinct roles
- 5
- Locations
By discipline
- Clinical17 68%
- Regulatory7 28%
- Quality1 4%
By level
- Director18 72%
- Senior & Principal5 20%
- VP & Executive1 4%
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Principal Scientist, Biostatistics, Late-Stage Clinical Development at Merck
Applications close November 24. $191K–$300K a year, employer provided.