Sr. Scientist, Statistical Programming- STDM, Hybrid
Sr. Scientist, Statistical Programming- STDM, Hybrid
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$ 114700 - 180500
1 Vacancy
Job Description
Job Description
In BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys renowned Research and Development division quantitative scientists in partnership with other subject matter experts apply stateofthe 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 Senior Statistical Programmer Submission Data Standards Quality Management (SDS QM) provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities coaching and consulting with project teams outreach to external vendors and partners and keeping current with industry submission data standards including SDTM ADaM clinical site data for CDER inspection planning etc.
The incumbent will be responsible for continuous improvement of our electronic submission process and providing tools and templates to support delivery focusing on traceability quality assurance data conformance and data fitness. The position is a key collaborator with statistical programming statistics regulatory and other project stakeholders.
Primary Activities:
PreNDA and PreBLA meeting preparation study data standards plan preparing questions for FDA edata mailboxes (CBER/CDER) attendance at meetings with regulatory agencies (FDA EMA PMDA)
Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise
Upversioning activities to specific versions of SDTM
Develop SAS Macros and Python Functions for SDTM Conversions.
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 stakeholders
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) SDRG ADRG
Experience with SAS and Python Programming for SDTM Conversions.
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:
Strong working knowledge of reporting processes (SOPs) and software development lifecycle (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
BARDS2020
SPjobs
VETJOBS
eligibleforERP
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 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 anothers 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 officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$114700.00 $180500.00Available 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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Business Business Clinical Data Clinical Databases Clinical Site Management Clinical Testing Clinical Trials Coaching Communication Computer Science Data Analysis Data Management Data Modeling Electronic Submissions Microsoft Project Numerical Analysis Process Improvement Projects Process Improvements Project Information Management Project Management Project Planning Regulatory Compliance SAS Macros Social Collaboration Software Development 8 morePreferred Skills:
Job Posting End Date:
06/13/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Senior IC
Employment Type
Full-Time
