Senior Director, Biostatistics

Fenningham, Dempster & Coval LLP; North Wales (Montgomery County); Hybrid; USD 206,000 - 325,000; Full time

Job summary

A leading pharmaceutical company is seeking a manager for the Translational Medicine Statistics group in their Research and Development division. This role entails overseeing a team of statisticians, providing statistical insight for clinical trials, and ensuring compliance with regulatory standards. Ideal candidates will have a PhD and extensive experience in clinical statistics, alongside a demonstrated ability to lead and collaborate in a cross-functional environment.

Benefits

Health care and other insurance benefits

Retirement benefits

Paid holidays, vacation, and sick days

Bonus eligibility

Qualifications

• PhD or MS in related field with significant experience in clinical trials.
• Excellent communication skills required.
• Ability to manage teams and cross-functional collaboration.

Responsibilities

• Manage a team of at least 5 statisticians.
• Provide statistical support for clinical trials.
• Collaborate with EDS Leadership Team on project guidance.

Skills

Biostatistics

Clinical Development

Communication

Data Analysis

Project Management

Education

PhD in statistics/epidemiology/data science

MS in statistics/epidemiology/data science

Tools

SAS Language

Job description

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: The Translational Medicine Statistics (TMS) group is a unit of the Early Development Statistics (EDS) department within the Biostatistics and Research Decision Sciences (BARDS) organization of Our Company's Research Laboratories. The primary responsibility of TMS is to provide statistical support for the pharmacology components of all clinical trials in our Company's Research Laboratories clinical development pipeline. Also in scope prior to an asset's potential advancement to late stage clinical development are proof of biology/concept clinical trials, experimental/discovery medicine trials involving novel pharmacodynamic endpoints/platforms, and early phase vaccine trials.

Reporting to the Executive Director and Head of TMS (in EDS/BARDS), the incumbent will manage a group of at least 5 statisticians. This requires a broad, comprehensive knowledge of statistics and its applications in clinical drug development.

Primary Activities:

• Report to the Executive Director and Head of TMS (in EDS/BARDS).
• Serve as a member of the EDS Leadership Team.
• Build/sustain a high performing statistics group to support translational medicine projects as a manager of at least 5 statisticians.
• Serve as a reviewer for the cross-functional translational medicine document review committee.
• Support due diligence in-licensing projects in the translational medicine space.
• Represent TMS on statistical matters involving regulatory interactions for assigned translational medicine projects.
• Support the development and deployment of state-of-the-art statistical methods for all in-scope projects.
• Support outsourcing efforts involving translational medicine activities.

Education and Minimum Requirements:

• PhD in statistics/epidemiology/data science with at least 10 years experience (or MS in statistics/epidemiology/data science with at least 12 years experience) in statistical design/analysis/reporting of clinical trials.

Required Skills and Experience: Excellent oral and written communication skills. Experience in collaborating with translational medicine and other clinical development professionals. Record of working effectively in a fast-paced cross-functional team environment. Working knowledge of requirements of clinical pharmacology components of regulatory filings.

Preferred Skills and Experience: Solid project management skills and the ability to partner with senior-level leaders across multiple departments. Understanding of the discovery, early-phase and late-phase clinical and translational drug development processes applicable to a broad portfolio of drug and vaccine candidates.

BARDS2020

#eligibleforERP

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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:

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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".

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:
$206,200.00 - $324,600.00

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.

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

Required Skills:
Biostatistics, Clinical Development, Clinical Pharmacology, Clinical Trials Analysis, Communication, Data Analysis, Data Management, Data Science, Drug Development, Numerical Analysis, Project Management, Project Support, Regulatory Submissions, SAS Language, Scientific Modeling, Statistical Analysis, Statistics, Written Communication

Preferred Skills:

Job Posting End Date:
06/8/2025
*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.

Requisition ID:R351119