- Address operational challenges that require strategic solutions, resulting in improved Clinical Study Report and filing completion timelines worldwide.
- Lead development of therapeutic areas- specific standard Tables, Listings, Figures (TLF) libraries
- Facilitate global adoption of therapeutic areas standards and programming best practices.
- Contribute to strategic solutions in support of internal stakeholder groups including the Outcomes Research and Clinical Safety organizations.
- Lead and actively contribute to departmental strategic initiative project teams.
- Excellent interpersonal skills and ability to negotiate and collaborate effectively.
- Excellent written, oral, and presentation skills
- Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for Research & Development projects (data, analyses, tables, graphics, listings)
- Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs effort others; ability to engage key stakeholders.
- Expertise in SAS and clinical trial programming
- Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and therapeutic area standards and according to quality, compliance and timeliness requirements.
- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
- Designs and develops complex programming algorithms.
- Familiarity with statistical analysis methods, terminology and concepts.
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Principal Scientist- Statistical Programmer - North Wales, United States - Merck
Description
Job Description
This position focuses on strategic activities impacting late-stage development therapeutic area (TA) projects to the direct benefit of project teams and the Biostatistics organization.
The position is a key collaborator with internal and external stakeholders including Statistics, Clinical Research, Regulatory, Observational Research, Clinical Safety and PK/PD Modeling and Simulation organizations.
Primary Activities:
Education and Minimum Requirement
:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12 years SAS programming experience in a clinical trial environment.
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years SAS programming experience in a clinical trial environment.
Department Required Skills and Experience:
Position Specific Required Skills and Experience:
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NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.
All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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, generally Tuesday, Wednesday and either Monday or 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".
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job.
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 salary range:
$164, $259,400.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
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:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
Requisition ID: R289603
