Senior Scientist, Cmc Statistics

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: Develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in CMC Statistics. Interacts with our company's Research Laboratories analytical, formulation and process development groups, Regulatory, Statistical Programming, Data Management, and with our company's Manufacturing Division functional areas in designing and analyzing CMC-related studies, and in coordinating other statistical activities for drug/vaccine projects.- This position may serve as a statistical lead in project teams. Responsible for supporting scientific projects or protocols. Independently balances activities for multiple projects. Represents function in cross-functional project teams; establishes collaborations /interactions with colleagues outside the department. Provides contribution to the successful completion of work critical to achieving department or project/ program goals; impacts therapeutic area decisions and direction. Participates in professional societies, technical associations and national standards committees.- Primary activities: Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development- Is involved in product development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory needs. Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of CMC-related studies, proposes solutions and carries them out. Contributes to individual protocols and develops data analysis plans and independently determines appropriate statistical methodology for analysis. Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology. Analyzes data and interprets results from CMC-related studies to meet objectives of the study protocol.- Independently applies and implements basic and complex statistical techniques to these analyses. Prepares oral and written reports to effectively communicate results to the project team, our company's Management, regulatory agencies, or individual scientists. Provides responses to queries relating to study design, analysis, and interpretation posed by scientists, Contract Research Organizations, and/or regulatory agencies.- May participate with manager in discussions with corresponding scientific personnel at regulatory agencies concerning proposed or ongoing studies. Involved in research activities for innovative statistical methods and applications. May provide mentoring and guidance to junior staff in functional activities. Education and Minimum Requirement: -
PhD or equivalent degree in statistics/biostatistics or related discipline or MS in Statistics/Applied Statistics with a minimum of 3 years relevant work experience. Required Skills and Experience : Knowledge of statistical analysis methodologies and experimental design.- Familiar with mixed models, variance component analysis, DOE, nonlinear regression, Bayesian analysis. Working knowledge of statistical and data processing software e.g., JMP, SAS and/or R.- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution. Ability to work independently. Good oral and written communication skills. Able to work effectively with personnel with different functional background. Preferred Skills and Experience: An understanding of biology of disease and drug discovery and development. BARDS2020
#eligibleforERP
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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.
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Expected salary range:
$111,400.00 - $175,300.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. - For Washington State Jobs, a summary of benefits is listed here . 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:
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06/6/2024
*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. Job Posting End Date: 06/06/2024
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: R295694