Associate Principal Scientist, Statistical Programming

Job Description

Primary Activities:

• Provide high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and global PK/PD modeling and simulation stakeholders spanning all therapeutic areas except oncology.

• Gather and interpret user requirements for analysis and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into analysis/modeling datasets, and develop tables and figures according to statistical/modeling analysis plan.

• Partner with stakeholders to solve problems; reduce the amount of programming task being completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses.

• Write programs to analyze data with statistical methods which are not currently available through commercial software packages.

• Act as a key collaborator with statisticians, modelers, and colleagues in other related function areas.

• Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data.

• Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses.

• Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation.

• Ensure programmatic traceability from data source to analysis/modeling result.

• Maintain and manage a project plan including resource forecasting.

• Support the development of programming standards to enable efficient and high-quality production of programming deliverables.

• Represent statistical programming on process improvement activities.

Required Education:

• Must have a Master’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least 7 years SAS programming experience in a clinical trial environment OR a Bachelor’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment.

Required Skills and Experience:

• Experience in CDISC SDTM and ADaM standards is also required.

• Must possess significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH and programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).

• Ability to design and develop complex programming algorithms; ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; and ability to implement statistical methods not currently available through commercial software packages required.

• Must have demonstrated success in the assurance of deliverable quality and process compliance and possess ability to thrive in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes; and ability to efficiently manipulate very large databases including complex data preprocessing, filtering, and manipulation.

• Must possess strategic thinking with ability to turn strategy into tactical activities; ability to design statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.

• Must possess 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 R&D projects (data, analyses, tables, graphics, listings); and strong project management skills; leadership at a program level; ability to determine approach and ensure consistency and directs development of others when opportunities arise; ability to engage key stakeholders.

Current Employees apply HERE

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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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.

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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”.

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

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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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

 Preferred Skills:

Job Posting End Date:

07/24/2025

*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.