Senior Scientist, Statistical Programming
Apply NowCompany: Merck & Co, Inc
Location: North Wales, PA 19454
Description:
Job Description
Primary Activities:
Provide support to statistical programming activities for late-stage drug/vaccine clinical development projects. Develop and execute statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. Design and maintain statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. Act as key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables. Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle for assigned projects. Perform effective analysis and report programming development and validation utilizing global and Therapeutic Area (TA) standards and following departmental standard operating procedures (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. Serve as a member on the departmental strategic initiative teams.
Eduactional Qualifications:
Positions Required skills and expereince:
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
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
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:
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
Job Posting End Date:
07/9/2025
*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.
Primary Activities:
Provide support to statistical programming activities for late-stage drug/vaccine clinical development projects. Develop and execute statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. Design and maintain statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. Act as key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables. Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle for assigned projects. Perform effective analysis and report programming development and validation utilizing global and Therapeutic Area (TA) standards and following departmental standard operating procedures (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. Serve as a member on the departmental strategic initiative teams.
Eduactional Qualifications:
- Must have a master's degree in computer science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least 3 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 at least 5 years SAS programming experience in a clinical trial environment.
Positions Required skills and expereince:
- Must have experience in CDISC and ADaM standards and in ensuring process compliance and deliverable quality.
- Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; and systems and database expertise also required.
- Applicant must also possess effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
- Effective interpersonal skills and ability to negotiate and collaborate effectively; effective written, oral, and presentation skills.
- Ability to design and develop complex programming algorithms; the ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts.
- Familiarity with clinical data management concepts; and ability to anticipate stakeholder requirements.
- Must be project leader with ability to complete tasks independently at a project level and ability to collaborate with key stakeholders.
- Ability to think strategically, specifically ability to turn strategy into tactical activities; and design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices also required.
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
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
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:
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
Job Posting End Date:
07/9/2025
*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.