Apellis Pharmaceuticals
Position
Director, Statistical Programming
at
Apellis Pharmaceuticals
Are you the right candidate for this opportunity Make sure to read the full description below. Position Summary
The Director, Statistical Programming will be responsible for leading and directing the statistical programming team and strategy for clinical projects across one or multiple therapeutic areas. Ensure delivery of high-quality programming deliverables in project timelines. Statistical Reporting representative on major Apellis initiatives. Location
Preferred job location: Waltham, MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided. Key Responsibilities
Operational and functional leadership of one or multiple therapeutic areas (TA). Lead and implement the statistical programming strategy in the responsible therapeutic area/s. Recruit, develop, mentor, coach people managers responsible for managing individual drug projects. Appraise the performance of direct and indirect reporting associates. Ensure high quality performance management and associates’ career development within his/her TAs. Establish high expectations and goals to ensure organizational success. Create an organization that executes efficiently and is committed to meeting goals. Encourage a culture of open, honest communication where all are encouraged to express their views. Manage quality, timeliness, efficiency, and implementation of standards within his/her Unit. Ensure implementation of state-of-the-art programming practices and quality guidelines in compliance with regulatory requirements and Apellis quality standards, to ensure programming deliverables of high quality, on time, and within budget. Build and maintain strong partnerships within Apellis Statistical Programming groups and across functions within Biometrics, Regulatory and all development functions. Attend Biometrics leadership meeting and extended leadership meeting to represent programming function on strategic and operational level. Lead all external and internal resource management activities across programming TAs, as well as contribute to the overall resource planning for programming. Manage and build relationships with external partners and service organizations. Engage in effective management of vendors including development, maintenance and monitoring of effective KPIs and KQIs. Anticipates potential problems within and across TAs and develops appropriate contingency plans. Create escalation plans to ensure resolution of all issues at the therapeutic and project levels. Lead independently improvement initiatives and/or non-clinical projects for programming and Biometrics. Ensure that relevant SOPs/BGs/Working practices are in place and followed. Review the planned contents of tables/listings/figures for SCS/SCE and project level documents to ensure efficient production and usefulness of output. Lead/participate in external industry/statistical programming activities and forums like PharmaSUG, SUGI, PHuse etc. Education, Registration & Certification
Post-graduate university or college degree in Life Sciences, Statistics, Mathematics, Computer Science, Medical Informatics or equivalent. Experience
12+ years of experience in global drug development, including at least 8 years in a senior programming/statistical role within the pharmaceutical industry. Strong leadership skills including leading people, operations, and innovation globally in complex matrix structures and business models. Superior interpersonal skills. At least 5 years of people management experience of staff across multiple sites. Good knowledge of drug development and commercialization processes. Proven ability to proactively identify issues, recommend and implement solutions. Strong global project management skills / Track record in successful project management. Good knowledge of statistical programming languages like SAS, R and R Shiny. Physical Demands And Work Environment This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Travel Requirements
Up to 15% travel expected. Benefits And Perks Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more. Visit the benefits page for details. Company Background Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that focuses on developing therapies for challenging diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn. EEO Statement Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. We prohibit discrimination based on race, color, religion, creed, national origin or ancestry, ethnicity, sex, gender identity, age, disability, citizenship, veteran status, genetic information, marital status, sexual orientation, or other protected characteristics. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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Director, Statistical Programming
at
Apellis Pharmaceuticals
Are you the right candidate for this opportunity Make sure to read the full description below. Position Summary
The Director, Statistical Programming will be responsible for leading and directing the statistical programming team and strategy for clinical projects across one or multiple therapeutic areas. Ensure delivery of high-quality programming deliverables in project timelines. Statistical Reporting representative on major Apellis initiatives. Location
Preferred job location: Waltham, MA. Remote candidates will be considered on a case-by-case basis or relocation may be provided. Key Responsibilities
Operational and functional leadership of one or multiple therapeutic areas (TA). Lead and implement the statistical programming strategy in the responsible therapeutic area/s. Recruit, develop, mentor, coach people managers responsible for managing individual drug projects. Appraise the performance of direct and indirect reporting associates. Ensure high quality performance management and associates’ career development within his/her TAs. Establish high expectations and goals to ensure organizational success. Create an organization that executes efficiently and is committed to meeting goals. Encourage a culture of open, honest communication where all are encouraged to express their views. Manage quality, timeliness, efficiency, and implementation of standards within his/her Unit. Ensure implementation of state-of-the-art programming practices and quality guidelines in compliance with regulatory requirements and Apellis quality standards, to ensure programming deliverables of high quality, on time, and within budget. Build and maintain strong partnerships within Apellis Statistical Programming groups and across functions within Biometrics, Regulatory and all development functions. Attend Biometrics leadership meeting and extended leadership meeting to represent programming function on strategic and operational level. Lead all external and internal resource management activities across programming TAs, as well as contribute to the overall resource planning for programming. Manage and build relationships with external partners and service organizations. Engage in effective management of vendors including development, maintenance and monitoring of effective KPIs and KQIs. Anticipates potential problems within and across TAs and develops appropriate contingency plans. Create escalation plans to ensure resolution of all issues at the therapeutic and project levels. Lead independently improvement initiatives and/or non-clinical projects for programming and Biometrics. Ensure that relevant SOPs/BGs/Working practices are in place and followed. Review the planned contents of tables/listings/figures for SCS/SCE and project level documents to ensure efficient production and usefulness of output. Lead/participate in external industry/statistical programming activities and forums like PharmaSUG, SUGI, PHuse etc. Education, Registration & Certification
Post-graduate university or college degree in Life Sciences, Statistics, Mathematics, Computer Science, Medical Informatics or equivalent. Experience
12+ years of experience in global drug development, including at least 8 years in a senior programming/statistical role within the pharmaceutical industry. Strong leadership skills including leading people, operations, and innovation globally in complex matrix structures and business models. Superior interpersonal skills. At least 5 years of people management experience of staff across multiple sites. Good knowledge of drug development and commercialization processes. Proven ability to proactively identify issues, recommend and implement solutions. Strong global project management skills / Track record in successful project management. Good knowledge of statistical programming languages like SAS, R and R Shiny. Physical Demands And Work Environment This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Travel Requirements
Up to 15% travel expected. Benefits And Perks Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more. Visit the benefits page for details. Company Background Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that focuses on developing therapies for challenging diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn. EEO Statement Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. We prohibit discrimination based on race, color, religion, creed, national origin or ancestry, ethnicity, sex, gender identity, age, disability, citizenship, veteran status, genetic information, marital status, sexual orientation, or other protected characteristics. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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